Contents

I. Oncology

A. Habib 2X Laparoscopic or Habib 4X Laparoscopic Devices

B. Habib 4X Device

C. Starburst Electrosurgical Devices (applies to StarBurst Model 75; StarBurst SDE Electrosurgical Device; StarBurst XL Electrosurgical Device; MRI Compatible StarBurst XL Device; and MRI Compatible StarBurst Semi-Flex Electrosurgical Device)

D. Starburst Xli-enhanced and Starburst SemiFlex Electrosurgical Devices

E. Talon Electrosurgical Device

F. UniBlate Electrosurgical Device

G. Alatus Vaginal Balloon Packing System

H. IsoLoc Gas-Release Endorectal Balloon

I. NanoKnife System

J. Solero Microwave Tissue Ablation (MTA) System

II. Vascular Access

A. Xcela Power Injectable PICC

B. Xcela™ PICC with PASV™ Valve Technology, Xcela™ Hybrid PICC with PASV™ Valve Technology

C. Vaxcel™ PICC with PASV™

D. BioFlo™ PICC with ENDEXO™ Technology, BioFlo™ PICC with ENDEXO™ and PASV™ Valve Technology, BioFlo™ Hybrid PICC with ENDEXO™ and PASV™ Valve Technology

E. LifePort and Vortex LP, TR, VX Ports

F. Vortex MP Ports

G. SmartPort Power Injectable Port Systems (SmartPort CT)

H. SmartPort Power Injectable Port Systems (SmartPort MP and LP)

I. BioFlo Port with ENDEXO Technology, BioFlo Port with ENDEXO and PASV Valve Technology, BioFlo Dual Port with ENDEXO Technology

J. Xcela™ Power Injectable Port

K. Xcela Plus Port, Xcela Plus Port with PASV Valve Technology

L. Vaxcel™ Implantable Vascular Access System with PASV Valve Technology

M. BioFlo Midline with ENDEXO Technology

N. Hemodialysis Catheter Repair Kit

O. PASV™ MS Kit with Pressure Activated Safety Valve

P. Lifeport Infusion Set

Q. Lifeguard Safety Needle

R. 16 Ga Straight Needle High Flow, Non-Coring

S. Micro Introducer

T. Perchik Button

U. EmboSafe™ Valved Peelable Introducer Sheath

V. Vaxcel™ Mini Stick Vascular Entry Kit Coaxial Dilator Set

W. Tearaway Sheath Introducer

X. Micro Access Kit

Y. Mini Stick II™ Microintroducer Kit

Z. SafeSheath ULTRALITE

AA. AngioDynamics® Introducer Products

BB. Vaxcel™ Mini Stick Vascular Entry Kit Peelable Introducer Sheath Set

CC. Vascular Guidewire NITINOL with Hydrophilic Coating

DD. BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter

EE. DuraMax Chronic Hemodialysis Catheter

FF. Dura-Flow™ LONG-TERM HEMODIALYSIS CATHETER with Hydro-Tip® catheter tip

GG. DuraFlow™ 2 CHRONIC HEMODIALYSIS CATHETER

HH. EVENMORE® LONGTERM HEMODIALYSIS CATHETER

II. SCHON XL®

JJ. FlowGuard Valved Peelable Introducer

KK. SmartPort+ and SmartPort Plastic Implantable Ports

LL. C3 Wave

MM. Biim Ultrasound System

III. Vascular Interventional Therapies/PAD

A. AngioVac Cannula (Generation 2)

B. AngioVac Cannula C20 and C180 (Generation 3)

C. AngioVac Circuit

D. VenaCure EVLT 1470 Laser

E. VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits; and VenaCure EVLT Tre’ Sheath

F. VenaCure EVLT OPS Procedure Kits

G. VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit (US ONLY)

H. VenaCure 1470 Pro Laser

I. VenaCure EVLT 400 Micron Fiber Procedure Kit

J. Uni*Fuse Infusion System

K. Pulse*Spray Infusion System

L. Nit-Vu Guidewires

M. Angiographic Guidewires

N. Angiographic Catheters (Soft-Vu, Accu-Vu, Mariner and AngiOptic)

O. AURYON Peripheral Atherectomy System

P. Drainage Catheters (Total Abscession)

Q. Drainage Catheters (Exodus)

R. Mini Stick ENVI Non-Vascular Introducer Kit

S. Mini Stick Max Coaxial MicroIntroducer Kit

T. Micro-introducer Kits and Accessories

I. Oncology

A. Habib 2X Laparoscopic or Habib 4X Laparoscopic Devices

1. Full Risk Information

Indications for Use: The Habib 4X or 2X Laparoscopic device is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures.

Contraindications: Do not use on patients with cardiac pacemakers or other active implants.

Warnings:

  • Do not attach anything (i.e., clamps, etc.) to the device. This may damage the insulation, which could contribute to patient injury.
  • Take care when handling as needles can cause injury.
  • Do not use if needles are bent or damaged, as it could lead to patient injury.
  • Please refer to the generator's user manual for warnings and precautions associated with the use of the generator.

Side Effects: The potential side effects associated with liver surgery are: general problems related to general anesthetics, bleeding, liver abscess, bile leak, liver failure, subphrenic abscess, postoperative heart failure, chest infection, wound dehiscence, wound infection or incisional hernia.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Habib 4X or 2X Laparoscopic device is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures.

Contraindications: Do not use on patients with cardiac pacemakers or other active implants.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Habib 4X or 2X Laparoscopic device is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

B. Habib 4X Device

1. Full Risk Information

Indications for Use: The Habib 4X device is intended to be used to assist in intraoperative coagulation of tissue during surgical procedures.

Contraindications: Do not use on patients with cardiac pacemakers or other active implants.

Warnings:

  • Do not attach anything (i.e., clamps, etc.) to the device. This may damage the insulation, which could contribute to patient injury.
  • Take care when handling as needles can cause injury.
  • Do not use if needles are bent or damaged, as it could lead to patient injury.
  • Please refer to the generator’s user manual for warnings and precautions associated with the use of the generator. Do not use Dispersive Pad(s) with the Habib 4X device. Using dispersive pad(s) will reduce the effectiveness of the Habib 4X device and will create an unintended current path from the Habib 4X electrode to the dispersive pad(s).

Side Effects: The potential side effects associated with liver surgery are: general problems related to general anesthetics, bleeding, liver abscess, bile leak, liver failure, subphrenic abscess, postoperative heart failure, chest infection, wound dehiscence, wound infection or incisional hernia.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Habib 4X device is intended to be used to assist in intraoperative coagulation of tissue during surgical procedures.

Contraindications: Do not use on patients with cardiac pacemakers or other active implants.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Habib 4X device is intended to be used to assist in intraoperative coagulation of tissue during surgical procedures.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

C. Starburst Electrosurgical Devices (applies to StarBurst Model 75; StarBurst SDE Electrosurgical Device; StarBurst XL Electrosurgical Device; MRI Compatible StarBurst XL Device; and MRI Compatible StarBurst Semi-Flex Electrosurgical Device)

1. Full Risk Information

Indications for Use: A tool to transmit energy (provided by the RITA® 1500 or 1500X RF Generator) for use in electrosurgery (ablation) in soft tissue, liver, and bone metastases.

Contraindications: None listed.

Warnings:

  • Do not attach anything (i.e., clamps, etc.) to the Device. This may damage the insulation, which could contribute to patient injury.
  • Do not bend or kink the trocar or the needles. This may cause damage and result in a non-functional device. Note: For the Semi-Flex device over bending the trocar to a radius smaller than 2 inches/5 cm, beyond 90° curvature, and/or kinking the device can damage the trocar, which could contribute to patient injury.
  • Do not twist or exert high forces on the device while it is deployed in the tissue. This may cause the needles to break and remain in the tissue.
  • Do not remove the Device without ensuring that the needles are fully retracted within the trocar.
  • Patients with peripheral vascular deficiency are at increased risk of thermal injury from Dispersive electrodes.
  • Patients with frail skin are at increased risk of skin damage from the adhesive on the Dispersive pads.
  • If the device is being used in a laparoscopic procedure, care must be taken to avoid a gas embolism.
  • Do not use metal introducers that do not have insulation. RF energy can be transmitted from the electrode through the un-insulated metal introducers to the patient, causing inadvertent burns.

Adverse Events: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: A tool to transmit energy (provided by the RITA® 1500 or 1500X RF Generator) for use in electrosurgery (ablation) in soft tissue, liver, and bone metastases.

Contraindications: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: A tool to transmit energy (provided by the RITA® 1500 or 1500X RF Generator) for use in electrosurgery (ablation) in soft tissue, liver, and bone metastases.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

D. Starburst Xli-enhanced and Starburst SemiFlex Electrosurgical Devices

1. Full Risk Information

Indications for Use: A tool to transmit energy (provided by the RITA® 1500X RF Generator) for use in electrosurgery (ablation) in soft tissue, liver, and bone metastases.

Contraindications: None listed.

Warnings:

  • Do not attach anything (i.e., clamps, etc.) to the Device. This may damage the insulation, which could contribute to patient injury.
  • For the non-SemiFlex device, do not bend or kink the trocar or the needles. This may cause damage and result in a non-functional device.
  • For SemiFlex Devices, over bending of the trocar to a radius smaller than 5 cm beyond a 90° curvature and/or kinking the device can damage the trocar and cause patient injury.
  • Do not twist or exert high forces on the Device while it is deployed in the tissue. This may cause the needles to break and remain in the tissue.
  • Do not remove the Device without ensuring that the needles are fully retracted within the trocar.
  • Do not attach anything (i.e. clamp, etc.) to the tubing set as this may result in a kinked or blocked fluid path, which may result in an unpredictable lesion.
  • Patients with peripheral vascular deficiency are at increased risk of thermal injury from Dispersive Electrodes. Patients with frail skin are at increased risk of skin damage from the adhesive on the Dispersive Electrodes.
  • Do not use metal introducers that do not have insulation. RF energy can be transmitted from the electrode through the un-insulated metal introducers to the patient, causing inadvertent burns.
  • If the device is being used in a laparoscopic procedure, care must be taken to avoid a gas embolism.

Adverse Events: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: A tool to transmit energy (provided by the RITA® 1500X RF Generator) for use in electrosurgery (ablation) in soft tissue, liver, and bone metastases.

Contraindications: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: A tool to transmit energy (provided by the RITA® 1500X RF Generator) for use in electrosurgery (ablation) in soft tissue, liver, and bone metastases.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

E. Talon Electrosurgical Device

1. Full Risk Information

Indications for Use: To be used in conjunction with the RITA RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue

Contraindications: None listed.

Warnings:

  • Do not attach anything (i.e., clamps, etc.) to the Device. This may damage the insulation, which could contribute to patient injury.
  • Do not twist or exert high forces on the device while it is deployed in the tissue. This may cause the needles to break and remain in the tissue.
  • Do not remove the Device without ensuring that the needles are fully retracted within the trocar. This may cause the needles to break and remain in the tissue.
  • If the device is being used in a laparoscopic procedure, care must be taken to avoid a gas embolism
  • For SemiFlex Talons: over bending of the trocar to a radius smaller than 5 cm beyond a 90° curvature and/or kinking the device can damage the trocar and cause patient injury.
  • Patients with peripheral vascular deficiency are at increased risk of thermal injury from Dispersive electrodes.
  • Patients with frail skin are at increased risk of skin damage from the adhesive on the Dispersive pads.
  • Do not use metal introducers that do not have insulation. RF energy can be transmitted from the electrode through the un-insulated metal introducers to the patient, causing inadvertent burns.
  • The Talon Electrosurgical Device is MR UNSAFE.

Adverse Events: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: To be used in conjunction with the RITA RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue.

Contraindications: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: To be used in conjunction with the RITA RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

F. UniBlate Electrosurgical Device

1. Full Risk Information

Indications for Use: To be used in conjunction with the RITA 1500X RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue.

Contraindications: None listed.

Warnings:

  • The distal 4 mm of the device is NOT Radio opaque and will not appear under CT imaging.
  • If the Tubing Set becomes occluded, improper or unpredictable lesion size may result.
  • Do not attach anything (i.e., clamps, etc.) to the device. This may damage the insulation, which could contribute to patient injury.
  • Patients with peripheral vascular deficiency are at increased risk of thermal injury from Dispersive electrodes.
  • Patients with frail skin are at increased risk of skin damage from the adhesive on the Dispersive pads.

Adverse Events: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: To be used in conjunction with the RITA 1500X RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue.

Contraindications: None listed.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: To be used in conjunction with the RITA 1500X RF Generator and IntelliFlow Infusion pump for the ablation of soft tissue.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

G. Alatus Vaginal Balloon Packing System

1. Full Risk Information

Indications for Use: The RadiaDyne Alatus Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Contraindications:

  • Vaginitis
  • Excessive vaginal bleeding
  • Any standard exclusionary criteria recognized for vaginal devices

Warnings:

  • Do not use if there are any outward signs of physical damage to the device.
  • The device is for Single Patient Use, and is a Single Use Device (SUD) only. The device cannot be sufficiently cleaned or sterilized to insure product performance or patient safety.
  • Patient injury may result from tampering with the device. Upon suspicion, please contact RadiaDyne immediately.
  • The RadiaDyne balloon should not remain inserted into the patient for any time longer than required for actual treatment.
  • If the patient cannon tolerate the balloon during treatment, stop and remove the balloon as described in the Insertion Technique section of these Instructions for Use. Technologists should promptly notify the treating Physician that the balloon was removed during treatment.
  • A new subsequent CT Scan and/or Treatment Plan may be required after stoppage and removal of the balloon per Physician’s orders.

Adverse Events: None specified

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The RadiaDyne Alatus Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Contraindications:

  • Vaginitis
  • Excessive vaginal bleeding
  • Any standard exclusionary criteria recognized for vaginal devices

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The RadiaDyne Alatus Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

H. IsoLoc Gas-Release Endorectal Balloon

1. Full Risk Information

Indications for Use: The RadiaDyne Prostate Immobilizer Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purposed of the device is to stabilize the prostate during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Contraindications:

  • Hemorrhoids
  • Peri-rectal / Peri-anal abscess
  • Anal Fissure, Anal Canal Stricture
  • Prior low anterior resection
  • Rectal Fistula, Rectal Fissure, Rectal Ulcer
  • Diverticulitis
  • Surgery of the prostate, rectum or surrounding area within the last eight
  • Weeks
  • Radiation of the rectum or surrounding area within the last eight weeks
  • Any standard exclusionary criteria recognized for endo-rectal / intra-rectal devices

Warnings:

  • Do not use if there are any outward signs of physical damage to the device.
  • The device is for Single Patient Use, and is a Single Use Device (SUD) only.
  • The device cannot be sufficiently cleaned or sterilized to insure product performance or patient safety.
  • Patient injury may result from tampering with the device. Upon suspicion, please contact RadiaDyne immediately.
  • The immobilizer device is not sterilized, nor is it compatible with sterilization procedures.
  • Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.
  • Do not transport patient from the treatment table with the immobilizer balloon inserted.
  • The balloon should be removed from the patient prior to transporting from the treatment table.
  • The RadiaDyne balloon should not remain inserted into the patient for any time longer than required for actual treatment.
  • Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.
  • If the patient cannot tolerate the rectal balloon during treatment, stop and remove the balloon as described in the Instructions for Use section. Therapist should promptly notify the treating Physician.
  • A new CT Scan and/or Treatment Plan may be required after stoppage of the balloon per Physician’s orders.
  • Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.

Adverse Events:

None specified

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The RadiaDyne Prostate Immobilizer Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purposed of the device is to stabilize the prostate during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Contraindications:

  • Hemorrhoids
  • Peri-rectal / Peri-anal abscess
  • Anal Fissure, Anal Canal Stricture
  • Prior low anterior resection
  • Rectal Fistula, Rectal Fissure, Rectal Ulcer
  • Diverticulitis
  • Surgery of the prostate, rectum or surrounding area within the last eight weeks
  • Radiation of the rectum or surrounding area within the last eight weeks
  • Any standard exclusionary criteria recognized for endo-rectal / intra-rectal devices

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The RadiaDyne Prostate Immobilizer Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purposed of the device is to stabilize the prostate during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

I. NanoKnife System

1. Full Risk Information

The NanoKnife System must be operated by properly qualified personnel only.

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Indications for Use:

US: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue.

OUS: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.

Contraindications:

Ablation procedures using the NanoKnife System are contraindicated in the following cases:

  • Ablation of lesions in the thoracic area in the presence of implanted cardiac pacemakers or defibrillators
  • Ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts.
  • Ablation of lesions of the eyes, including the eyelids.
  • Patient history of Epilepsy or Cardiac Arrhythmia
  • Recent history of Myocardial Infarction.

Warnings:

Clinical Issues (including Arrhythmia, Hypertension, and Thrombus Risks)

  • Patients with Q-T intervals greater than 500 ms (milliseconds) are at an increased risk for inappropriate energy delivery and arrhythmia. Verification of proper function of a synchronization device before initiating energy delivery is essential in these patients.
  • Asynchronous energy delivery (90 PPM (Pulses Per Minute)) might trigger atrial or ventricular fibrillation, especially in patients with structural heart disease. Ensure that proper interventions (e.g. defibrillator) and appropriately trained personnel are readily available for dealing with potential cardiac arrhythmias.
  • Using QRS synchronization devices whose output is not compatible with the specifications listed in this manual may result in arrhythmias including ventricular fibrillation.
  • Adequate precautions should be taken for patients with implantable electrical devices. Note the contraindication in certain patients.
  • There are potential risks associated with the location of the ablation: near the pericardium (tachycardia), or near the vagus nerve (bradycardia).
  • Additional patients may be at risk with insufficient muscle blockade or anesthetic analgesia (reflex tachycardia and reflex hypertension); patients with abnormal sinus rhythm prior to an ablation (arrhythmia); patients with a history of hypertension (hypertension); or patients with partial portal venous thrombosis, low central venous pressure (CVP), and a prothrombotic condition (venous thrombosis).

Use of Electrodes

  • Avoid repeated vascular insult during electrode placement.
  • As anticipated with a needle-related procedure, repeated vascular insult due to multiple insertions into a vessel by an electrode during electrode placement may cause thrombus.
  • Ensure continuous image guidance during the needle placements. Failure to do so can lead to traumatic injury to surrounding structures.
  • Care should be taken during electrode placement in areas that require tissue be separated or retracted to avoid surrounding tissue damage.
  • To avoid risks of infection, always maintain the electrodes’ protective packaging (cap, tubes, etc.) when the electrodes are not placed in the patient.
  • Only electrode probes with intact electrical insulation must be used. Any electrodes with damaged electrical insulation must be discarded immediately and not connected to the NanoKnife Generator.
  • To preserve the electrode’s sterility do not remove the electrodes from the packaging until the User is ready to apply the electrode to the patient.
  • Do not use the electrodes after the expiration date printed on their packaging. Observe the electrodes manufacturer’s specific instructions (e.g., printed on the electrodes’ packaging).
  • Only use AngioDynamics Electrode Probes with the NanoKnife System Generator.
  • Maintain electrical separation of the electrodes from safety ground by doing the following
  • Disconnect any electrode from the Generator that is not applied to the patient.
  • Avoid any clamping of the electrode’s cable, unless explicitly instructed or authorized by the electrode’s manufacturer.
  • Do not connect any devices (e.g., measurement) to the electrodes unless they have been supplied by and specifically indicated for such a use by the manufacturer.

Use of Generator (including Electrocution Hazard)

  • No modification of this equipment is allowed.
  • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
  • The Generator internally produces voltages that are dangerous and may be fatal. The Generator does not contain parts serviceable by the User, and should not be opened.
  • Do not use the Generator in the presence of flammable or explosive gas mixtures.
  • For electrical safety, the Generator needs grounding. Use only medical grade main power supply cords, e.g., those supplied by the manufacturer.
  • Before plugging the Generator to the main, ensure that the main power cords are not damaged. Replace them if any damage is noticed - main cords cannot be repaired.
  • Do not connect or disconnect the Generator from the main power cord with wet hands.
  • Confirm that the main power cord will be connected to a properly grounded electrical outlet.
  • Whenever necessary, replace Generator fuses only with fuses specified in this manual.
  • Maintenance should be carried out only by trained personnel. The Generator must undergo periodic preventative maintenance as specified in the Maintenance and Service.
  • The NanoKnife User Manual is a fundamental part of the Generator and should always accompany it. Users must refer to this manual for correct and complete information on the use of the Generator.

Adverse Events:

Adverse effects that may be associated with the use of the NanoKnife system include, but are not limited to the following:

  • Arrhythmia
  • Atrial fibrillation or flutter
  • Bigeminy
  • Bradycardia
  • Heart block or atrioventricular block
  • Paroxysmal supraventricular tachycardia
  • Tachycardia
    • Reflex tachycardia
    • Ventricular tachycardia
  • Ventricular fibrillation
  • Damage to critical anatomical structure (nerve, vessel, and/or duct)
  • Fistula formation
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Infection
  • Pneumothorax
  • Reflex Hypertension
  • Unintended mechanical perforation
  • Vagal Stimulation, asystole
  • Venous Thrombosis

2. Abbreviated Risk Information

The NanoKnife System must be operated by properly qualified personnel only.

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Indications for Use:

US: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue.

OUS: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.

Contraindications:

Ablation procedures using the NanoKnife System are contraindicated in the following cases:

Ablation of lesions in the thoracic area in the presence of implanted cardiac pacemakers or defibrillators

Ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts.

Ablation of lesions of the eyes, including the eyelids.

Patient history of Epilepsy or Cardiac Arrhythmia

Recent history of Myocardial Infarction.

3. Limited Risk Information

The NanoKnife System must be operated by properly qualified personnel only.

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Indications for Use:

US: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue.

OUS: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.

J. Solero Microwave Tissue Ablation (MTA) System

1. Full/Abbreviated Risk Information

Indications for Use:

US: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

CE: The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue* during open, laparoscopic, or percutaneous procedures. The Solero MTA System is not intended for cardiac use.

*Note Canada Only: Throughout this document any reference to “soft tissue” means the following tissue types: Liver, Kidney, and Lung (early stage non-small cell lung cancer (NSCLC) and inoperable pulmonary malignancies).

Contraindications:

The applicators are contraindicated in patients with heart pacemakers and other electronic device implants.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Indications for Use:

US: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

CE: The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue* during open, laparoscopic, or percutaneous procedures. The Solero MTA System is not intended for cardiac use.

*Note Canada Only: Throughout this document any reference to “soft tissue” means the following tissue types: Liver, Kidney, and Lung (early stage non-small cell lung cancer (NSCLC) and inoperable pulmonary malignancies).

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

II. Vascular Access

A. Xcela Power Injectable PICC

1. Full Risk Information 

Indications for Use: The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortion of the veins from surgery, injury or trauma
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Warnings:

  • Do not use if package is opened or damaged.
  • If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
  • Do not fully insert catheter up to suture wing.
  • Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.
  • Do not place the catheter into the right atrium of the heart.
  • Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.
  • Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
  • Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter.
  • Exceeding the maximum allowable flow rate (Table 2) may result in catheter failure and/or catheter tip displacement.
  • Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.
  • The maximum pressure of power injectors used with the power injectable PICC must not exceed 300 psi (2,068 kPa).

Adverse Events:

  • Air Embolism
  • Bleeding
  • Cardiac Arrhythmia
  • Cardiac Puncture
  • Cardiac Tamponade
  • Catheter Dislodgement
  • Catheter Embolism
  • Catheter Erosion through Skin/Vessel
  • Catheter Fragmentation
  • Catheter Malfunction
  • Catheter Malposition
  • Catheter Migration
  • Catheter Occlusion
  • Catheter Retraction
  • Catheter Rupture
  • Death
  • Drug or Contrast Medium Extravasation
  • Drug or Contrast Medium Precipitate
  • Embolism
  • Endocarditis
  • Exit Site Necrosis
  • Fibrin Sheath Formation
  • Foreign Body Rejection
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Infection
  • Inflammation/Phlebitis
  • Intolerance Reaction to Contrast Media
  • Intolerance Reaction to Implanted Device
  • Myocardial Erosion
  • Nerve Damage
  • Pain
  • Pneumothorax
  • Renal Compromise
  • Sepsis
  • Subintimal Venous or Myocardial Injection
  • Thoracic Duct Injury
  • Thrombophlebitis
  • Vascular Thrombosis
  • Vessel Damage

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortion of the veins from surgery, injury or trauma
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

B. Xcela™ PICC with PASV™ Valve Technology, Xcela™ Hybrid PICC with PASV™ Valve Technology

1. Full Risk Information 

Indications for Use: The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortion of the veins from surgery, injury or trauma
  • Inadequate antecubital veins
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Warnings:

Refer to procedural steps for additional warnings. Due to the risk of exposure to bloodborne pathogens, care providers must adhere to guidelines for universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.

  • Do not use if package is opened or damaged.
  • If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
  • Do not fully insert catheter up to suture wing.
  • Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.
  • Do not place the catheter into the right atrium or the right ventricle of the heart.
  • Do not resheath any needles. Place needles in puncture resistant, leak proof, sharps containers per institutional protocol.
  • Do not attempt to trim the catheter with the guidewire or stylet loaded as catheter, stylet, or guidewire may become damaged resulting in patient injury.
  • Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.
  • Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
  • Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter.
  • Exceeding the maximum allowable flow rate (Table 2) may result in catheter failure and/or catheter tip displacement.
  • Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.
  • The maximum pressure of power injectors used with the Power Injectable PICC must not exceed 325 psi (2,240 kPa).
  • Prior to loading stylet or guidewire cut catheter to desired length. Do not cut catheter while stylet or guidewire is loaded into catheter as device damage or patient injury may occur.

Additional warning for Xcela Hybrid PICC with PASV Valve Technology - Central Venous Pressure (CVP) Monitoring should always be used in conjunction with other patient assessment metrics when evaluating cardiac function.

Adverse Events:

  • Air Embolism
  • Bleeding
  • Brachial Plexus or Other Nerve Injury
  • Cardiac Arrhythmia
  • Cardiac Puncture
  • Cardiac Tamponade
  • Catheter Dislodgement
  • Catheter Embolism
  • Catheter Erosion through Skin/Vessel
  • Catheter Fragmentation
  • Catheter Malfunction
  • Catheter Malposition
  • Catheter Migration
  • Catheter Occlusion
  • Catheter Retraction
  • Catheter Rupture
  • Death
  • Drug or Contrast Medium Precipitate
  • Extravasation/Infiltration of Infusate
  • Embolism
  • Endocarditis
  • Exit Site Necrosis
  • Fibrin Sheath Formation
  • Foreign Body Rejection
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Infection
  • Inflammation/Phlebitis
  • Intolerance Reaction to Contrast Media
  • Intolerance Reaction to Implantation Device
  • Malposition
  • Myocardial Erosion
  • Nerve Damage
  • Pain
  • Pericardial Effusion
  • Pleural Effusion
  • Pneumothorax
  • Pulmonary Embolism
  • Renal Compromise
  • Sensitivity or Allergy
  • Sepsis
  • Subintimal Venous or Myocardial Injection
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Vascular Thrombosis
  • Vessel Damage
  • Vessel Stenosis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortion of the veins from surgery, injury or trauma
  • Inadequate antecubital veins
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

C. Vaxcel™ PICC with PASV™

1. Full Risk Information 

Indications for Use: The Vaxcel PICC with PASV Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

Contraindications:

  • Venous thrombosis in all or any portion of the vein where the catheter is expected to reside
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices such as pacemakers
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Inadequate antecubital veins
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortions from surgery, injury or trauma
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Warnings:

  • Due to the risk of exposure to HIV (Human Immunodeficiency Virus) and/or other bloodborne pathogens, health care workers should routinely use universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.
  • Do not resheath any needles. Place needles in puncture resistant, leak proof, sharps containers per institutional protocol.
  • If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
  • Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.

Adverse Events:

  • Air Embolism
  • Bleeding
  • Cardiac Arrhythmia
  • Catheter Erosion Through Skin/Vessel
  • Catheter Fragmentation
  • Catheter Migration
  • Catheter Occulsion
  • Catheter Rupture
  • Central Vein Stenosis
  • Death
  • Drug Extravasation
  • Drug Precipitate
  • Endocarditis
  • Exit Site Necrosis
  • Fibrin Sheath Formation
  • Foreign Body Rejection
  • Hematoma
  • Infection
  • Malposition
  • Pain
  • Perforation of Vessel
  • Thromboembolism
  • Thrombophlebitis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Vaxcel PICC with PASV Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

Contraindications:

  • Venous thrombosis in all or any portion of the vein where the catheter is expected to reside
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices such as pacemakers
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Inadequate antecubital veins
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortions from surgery, injury or trauma
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Vaxcel PICC with PASV Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

D. BioFlo™ PICC with ENDEXO™ Technology, BioFlo™ PICC with ENDEXO™ and PASV™ Valve Technology, BioFlo™ Hybrid PICC with ENDEXO™ and PASV™ Valve Technology

1. Full Risk Information

Indications for Use: The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.

The BioFlo PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Nonvalved lumens are indicated for central venous pressure monitoring.

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortion of the veins from surgery, injury or trauma
  • Inadequate antecubital veins
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Warnings:

Refer to procedural steps for additional warnings. Due to the risk of exposure to bloodborne pathogens, care providers must adhere to guidelines for universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.

  • Do not use if package is opened or damaged.
  • If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
  • Do not fully insert catheter up to suture wing.
  • Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.
  • Do not place the catheter into the right atrium or the right ventricle of the heart.
  • Do not resheath any needles. Place needles in puncture resistant, leak proof, sharps containers per institutional protocol.
  • Do not attempt to trim the catheter with the guidewire or stylet loaded as catheter, stylet, or guidewire may become damaged resulting in patient injury.
  • Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.
  • Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
  • Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter.
  • Exceeding the maximum allowable flow rate (Table 2) may result in catheter failure and/or catheter tip displacement.
  • Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.
  • The maximum pressure of power injectors used with the Power Injectable PICC must not exceed 325 psi (2,240 kPa).
  • Prior to loading stylet or guidewire cut catheter to desired length. Do not cut catheter while stylet or guidewire is loaded into catheter as device damage or patient injury may occur.

Additional warning for BioFlo™ PICC with ENDEXO™ Technology and BioFlo™ Hybrid PICC with ENDEXO™ and PASV™ Valve Technology - Central Venous Pressure (CVP) Monitoring should always be used in conjunction with other patient assessment metrics when evaluating cardiac function.

Adverse Events:

  • Air Embolism
  • Bleeding
  • Brachial Plexus or Other Nerve Injury
  • Cardiac Arrhythmia
  • Cardiac Puncture
  • Cardiac Tamponade
  • Catheter Dislodgement
  • Catheter Embolism
  • Catheter Erosion through Skin/Vessel
  • Catheter Fragmentation
  • Catheter Malfunction
  • Catheter Malposition
  • Catheter Migration
  • Catheter Occlusion
  • Catheter Retraction
  • Catheter Rupture
  • Death
  • Drug or Contrast Medium Precipitate
  • Extravasation/Infiltration of Infusate
  • Embolism
  • Endocarditis
  • Exit Site Necrosis
  • Fibrin Sheath Formation
  • Foreign Body Rejection
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Infection
  • Inflammation/Phlebitis
  • Intolerance Reaction to Contrast Media
  • Intolerance Reaction to Implantation Device
  • Malposition
  • Myocardial Erosion
  • Nerve Damage
  • Pain
  • Pericardial Effusion
  • Pleural Effusion
  • Pneumothorax
  • Pulmonary Embolism
  • Renal Compromise
  • Sensitivity or Allergy
  • Sepsis
  • Subintimal Venous or Myocardial Injection
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Vascular Thrombosis
  • Vessel Damage
  • Vessel Stenosis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.

The BioFlo PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Nonvalved lumens are indicated for central venous pressure monitoring.

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
  • Orthopedic or neurological conditions affecting the extremity
  • Anticipation or presence of dialysis grafts or other intraluminal devices
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
  • Anatomical distortion of the veins from surgery, injury or trauma
  • Inadequate antecubital veins
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.

The BioFlo PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Nonvalved lumens are indicated for central venous pressure monitoring.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

E. LifePort and Vortex LP, TR, VX Ports

1. Full Risk Information 

Indications for Use: The AngioDynamics port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. Dual models are indicated for combination therapy, simultaneous infusions, withdrawal of body fluids, and bolus delivery during continuous infusion.

Contraindications:

AngioDynamics port systems should not be implanted in the presence of known or suspected infections, bacteremia, septicemia, and peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.

Warnings:

ONLY Federal Law (USA) restricts the device to sale by or on the order of a physician.

  • The Port is for single use only.
  • Re-use of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Do not re-sterilize the port or accessories by any method. Reprocessing may compromise the integrity of the device and/or lead to device failure.
  • The manufacturer shall not be liable for damages caused by the re-use or resterilization of the port or accessories.
  • Contents sterile in unopened, undamaged package.
  • Sterilized via Ethylene Oxide.
  • Do not use port or accessories if package is opened or damaged.
  • Do not use port or accessories if any sign of product damage is visible.

Potential Complications:

Use of AngioDynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to:

Infection; occlusion; thrombophlebitis, pneumothorax; catheter malposition; migration and inadequate anchoring; hemorrhage; vessel trauma, including puncture, laceration, and erosion of vessel and the skin; catheter pinch-off (compression of the catheter between the clavicle and the first rib); hematoma; clot formation; catheter fragmentation; embolization; cardiac arrhythmia; cardiac puncture; cardiac tamponade; fibrin sheath, endocarditis; implant rejection; thoracic duct injury; thromboembolism; peritonitis; thrombosis; and drug extravasation (leakage).

Occlusion may result from clot formation inside the lumen of the catheter, precipitate formation inside the port from incompatible drugs, or from catheter tip placement against a vein wall or valve.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The AngioDynamics port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. Dual models are indicated for combination therapy, simultaneous infusions, withdrawal of body fluids, and bolus delivery during continuous infusion.

Contraindications:

AngioDynamics port systems should not be implanted in the presence of known or suspected infections, bacteremia, septicemia, and peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The AngioDynamics port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. Dual models are indicated for combination therapy, simultaneous infusions, withdrawal of body fluids, and bolus delivery during continuous infusion.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

F. Vortex MP Ports

1. Full Risk Information 

Indications for Use: Vortex MP Port models MP-P5PT, MP-P5PK, MP-P5SAT, and MP-P5SDT are indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Contraindications:

The Vortex MP Port should not be implanted whenever:

  • The planned drug therapy requires the use of substances known to be incompatible with the materials of construction.
  • The patient is suspected to have an allergic reaction to the materials of construction or has exhibited prior intolerance to device implants.
  • There is a known or suspected infection, bacteremia, septicemia or peritonitis, unless access to the vascular system with the Vortex MP Port system is the method by which the infection or sepsis is to be treated.

Warnings:

ONLY Federal Law (USA) restricts the device to sale by or on the order of a physician.

  • The Port is for single use only
  • Re-use of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Do not re-sterilize the port or accessories by any method.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.
  • The manufacturer shall not be liable for damages caused by the re-use or resterilization of the port or accessories.
  • Contents sterile in unopened, undamaged package.
  • Sterilized via Ethylene Oxide
  • Do not use port or accessories if package is opened or damaged.
  • Do not use port or accessories if any sign of product damage is visible.
  • Clamp infusion set when not in use.

Potential Complications:

Use of the system involves potential risks associated with any implanted device or indwelling catheter. They include, but are not limited to:

  • Air embolism
  • Bleeding
  • Cardiac arrhythmia
  • Cardiac tamponade
  • Catheter disconnection or migration
  • Catheter fracture, including “Pinch-Off Syndrome”
  • Chylothorax
  • Device rejection
  • Device rotation or extrusion
  • Endocarditis
  • Extravasation
  • Fibrin sheath formation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Infection
  • Inflammation, necrosis or scarring of skin over implant area
  • Occlusion
  • Peripheral nerve damage
  • Pneumothorax
  • Right atrial puncture
  • Surgical complications
  • Thoracic duct injury
  • Thromboembolism
  • Thrombophlebitis
  • Thrombosis
  • Vein puncture

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: Vortex MP Port models MP-P5PT, MP-P5PK, MP-P5SAT, and MP-P5SDT are indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Contraindications:

The Vortex MP Port should not be implanted whenever:

  • The planned drug therapy requires the use of substances known to be incompatible with the materials of construction.
  • The patient is suspected to have an allergic reaction to the materials of construction or has exhibited prior intolerance to device implants.
  • There is a known or suspected infection, bacteremia, septicemia or peritonitis, unless access to the vascular system with the Vortex MP Port system is the method by which the infection or sepsis is to be treated.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: Vortex MP Port models MP-P5PT, MP-P5PK, MP-P5SAT, and MP-P5SDT are indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

G. SmartPort Power Injectable Port Systems (SmartPort CT)

1. Full Risk Information 

Indications for Use: The Smart Port CT power injectable port line is indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Warnings:

  • The device is to be implanted, used, maintained, and removed in strict accordance with institutional and or Centers for Disease Control (CDC) guidelines or policies.
  • During placement through a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism or patient injury may occur. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver.
  • Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity.
  • Do not use syringes smaller than 10 ml when accessing the port as system damage can occur. Flushing occluded catheters with small syringes can create excessive pressures within the port system.
  • Failure to use a power injectable needle with the Smart Port for a power injection procedure may result in port system failure and patient injury may occur.
  • Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.
  • Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.
  • Failure to warm contrast media to body temperature may result in port system failure and patient injury may occur.
  • Do not exceed 300 psi pressure limit setting or the maximum recommended flow rate setting. Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement and patient injury may occur. The power injection machine may not prevent over pressurization in the presence of occlusion or resistance.
  • Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, Pinch-Off Syndrome, fibrin formation, thrombosis or malposition. This should be evaluated prior to device usage. A blood return should be present prior to usage of device for any therapy or testing.
  • Do not attempt to measure the patient’s blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.
  • If the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, Pinch-Off Syndrome, thrombosis or malposition. Failure to assess these complaints or observations can lead to device failure.
  • Power injection machine pressure limiting (safety cut-off) settings may not prevent over pressurization of an occluded device.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.
  • Review all fluids to be used with this product for any incompatibility with plastics and plastic adhesives.
  • Maximum pressure recommended for power injection of contrast media with the Smart Port CT implantable ports is 300 psi and a maximum flow rate of 5ml/sec.
  • Only LifeGuard 19 and 20 gauge non Y-Site needle models may be utilized for power injection with Smart Port CT.
  • Clamp infusion set when not in use.

Potential Complications:

Use of an AngioDynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to:

These complications are well documented in literature and should be considered when a venous access device is utilized.

  • Air embolism
  • Bleeding
  • Cardiac arrhythmia
  • Cardiac puncture
  • Cardiac tamponade
  • Catheter disconnection or migration
  • Catheter embolization
  • Catheter fragmentation
  • Catheter malposition
  • Catheter Pinch-off
  • Chylothorax
  • Clot formation
  • Device rotation
  • Drug extravasation (leakage)
  • Endocarditis
  • Erosion of vessel and skin
  • Fibrin sheath
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Implant rejection
  • Inadequate anchoring
  • Infection
  • Inflammation
  • Laceration
  • Migration
  • Necrosis or scarring of skin over implant area
  • Occlusion
  • Peripheral nerve damage
  • Peritonitis
  • Pneumothorax
  • Puncture of Vessel
  • Right arterial puncture
  • Surgical complications
  • Thoracic duct injury
  • Thromboembolism
  • Thrombophlebitis
  • Thrombosis
  • Twiddler Syndrome
  • Vein puncture
  • Vessel trauma

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Smart Port CT power injectable port line is indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Smart Port CT power injectable port line is indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

H. SmartPort Power Injectable Port Systems (SmartPort MP and LP)

1. Full Risk Information 

Indications for Use: The Smart Port CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Warnings:

  • The device is to be implanted, used, maintained, and removed in strict accordance with institutional and or Centers for Disease Control (CDC) guidelines or policies.
  • During placement through a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism or patient injury may occur. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver.
  • Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity.
  • Do not use syringes smaller than 10 ml when accessing the port as system damage can occur. Flushing occluded catheters with small syringes can create excessive pressures within the port system.
  • Failure to use a power injectable needle with the Smart Port for a power injection procedure may result in port system failure and patient injury may occur.
  • Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.
  • Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.
  • Failure to warm contrast media to body temperature may result in port system failure and patient injury may occur.
  • Do not exceed 300 psi pressure limit setting or the maximum recommended flow rate setting. Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement and patient injury may occur. The power injection machine may not prevent over pressurization in the presence of occlusion or resistance.
  • Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, Pinch-Off Syndrome, fibrin formation, thrombosis or malposition. This should be evaluated prior to device usage. A blood return should be present prior to usage of device for any therapy or testing.
  • Do not attempt to measure the patient’s blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.
  • If the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, Pinch-Off Syndrome, thrombosis or malposition. Failure to assess these complaints or observations can lead to device failure.
  • Power injection machine pressure limiting (safety cut-off) settings may not prevent over pressurization of an occluded device.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.
  • Review all fluids to be used with this product for any incompatibility with plastics and plastic adhesives.
  • Maximum pressure recommended for power injection of contrast media with the Smart Port CT implantable ports is 300 psi and a maximum flow rate of 5ml/sec.
  • Only LifeGuard 19 and 20 gauge non Y-Site needle models may be utilized for power injection with Smart Port CT.
  • Clamp infusion set when not in use.

Potential Complications:

Use of an AngioDynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to:

These complications are well documented in literature and should be considered when a venous access device is utilized.

  • Air embolism
  • Bleeding
  • Cardiac arrhythmia
  • Cardiac puncture
  • Cardiac tamponade
  • Catheter disconnection or migration
  • Catheter embolization
  • Catheter fragmentation
  • Catheter malposition
  • Catheter Pinch-off
  • Chylothorax
  • Clot formation
  • Device rotation
  • Drug extravasation (leakage)
  • Endocarditis
  • Erosion of vessel and skin
  • Fibrin sheath
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Implant rejection
  • Inadequate anchoring
  • Infection
  • Inflammation
  • Laceration
  • Migration Necrosis or scarring of skin over implant area
  • Occlusion
  • Peripheral nerve damage
  • Peritonitis
  • Pneumothorax
  • Puncture of Vessel
  • Right arterial puncture
  • Surgical complications
  • Thoracic duct injury
  • Thromboembolism
  • Thrombophlebitis
  • Thrombosis
  • Twiddler Syndrome
  • Vein puncture
  • Vessel trauma

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Smart Port CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Smart Port CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

I. BioFlo Port with ENDEXO Technology, BioFlo Port with ENDEXO and PASV Valve Technology, BioFlo Dual Port with ENDEXO Technology

1. Full Risk Information 

Indications for Use: The BioFlo Port with ENDEXO Technology, BioFlo Dual Port with ENDEXO Technology and the BioFlo Port with ENDEXO and PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the BioFlo Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mL/sec with a 19G or 20G non-coring power injectable needle or 2 mL/sec with a 22G non-coring power injectable needle.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Warnings:

  • The device is to be implanted, used, maintained, and removed in strict accordance with institutional and or Centers for Disease Control (CDC) guidelines or policies.
  • During placement through a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism or patient injury may occur. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver.
  • Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity.
  • Do not use syringes smaller than 10 ml when accessing the port as system damage can occur. Flushing occluded catheters with small syringes can create excessive pressures within the port system.
  • Failure to use a power injectable needle with the BioFlo Port for a power injection procedure may result in port system failure and patient injury may occur.
  • Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.
  • Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.
  • Failure to warm contrast media to body temperature may result in port system failure and patient injury may occur.
  • Do not exceed 300 psi (2068 kPa) pressure limit setting or the maximum recommended flow rate setting. Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement and patient injury may occur.
  • If local pain, swelling or signs of extravasation are noted, the injection should be stopped immediately as patient injury may occur.

Adverse Events:

  • Air or Catheter (or Catheter Fragments) Embolism
  • Arteriovenous Fistula
  • Bacteremia
  • Bleeding
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Catheter or Port Erosion through skin/vessel
  • Catheter Occlusion, Malposition, Dislodgment, Fragmentation, Migration, Disconnection or Rupture
  • Catheter Occlusion or Breakage caused by pinching between clavicle and first rib
  • Catheter Thrombosis
  • Death
  • Drug Extravasation
  • Endocarditis
  • Fibrin Sheath Formation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Inflammation
  • Infection
  • Implant rejection
  • Implant rotation or extrusion
  • Implantation site Necrosis or Infection
  • Laceration or Perforation of Vessel
  • Nerve Damage
  • Pneumothorax
  • Risks normally associated with Local and General Anesthesia, Surgery, and Post-operative recovery
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Tunnel infection
  • Vascular Thrombosis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The BioFlo Port with ENDEXO Technology, BioFlo Dual Port with ENDEXO Technology and the BioFlo Port with ENDEXO and PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the BioFlo Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mL/sec with a 19G or 20G non-coring power injectable needle or 2 mL/sec with a 22G non-coring power injectable needle.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The BioFlo Port with ENDEXO Technology, BioFlo Dual Port with ENDEXO Technology and the BioFlo Port with ENDEXO and PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the BioFlo Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mL/sec with a 19G or 20G non-coring power injectable needle or 2 mL/sec with a 22G non-coring power injectable needle.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

J. Xcela™ Power Injectable Port

1. Full Risk Information 

Indications for Use: The Xcela Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Xcela™ Power Injectable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/sec with a 19 G or 20 G non-coring power injectable needle or 2 mL/sec with a 22 G non-coring power injectable needle.

Absolute Contraindications

This device is not designed, sold or intended for use except as indicated.

The port system must not be used in case of:

  • inadequate body tissue to support the device
  • bacteremia
  • sepsis
  • known or suspected allergic response to the materials
  • severe chronic obstructive lung disease exists
  • past irradiation of prospective insertion site
  • previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site
  • local tissue factors will prevent proper device stabilization and/or access

Warnings:

  • Intended for Single Patient Use. DO NOT REUSE
  • The Xcela Power Injectable Port is a single use device and should never be reimplanted. Reuse carries with it the attendant concern of cross-infection regardless of the cleaning or sterilization method. Re-sterilization of incompletely cleaned devices may not be effective. Any device that has been contaminated by blood should not be reused or sterilized.
  • After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
  • Pinch-Off Prevention: Catheters placed percutaneously or through a cut-down into the subclavian vein should be inserted at the junction of the outer and middle thirds of the clavicle, lateral to the thoracic outlet. The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle, which can cause damage and even severance of the catheter. A radiographic confirmation of catheter placement should be made to ensure that the catheter is not being pinched by the first rib and clavicle.

Possible Complications:

The use of a subcutaneous port provides an important means of venous access for critically ill patients; however, the potential exists for serious complications including the following:

  • air embolism
  • bleeding
  • brachial plexus injury
  • cardiac arrhythmia
  • cardiac tamponade
  • catheter or port-related sepsis
  • catheter or port erosion through the skin
  • catheter occlusion, damage or breakage due to compression between the clavicle and first rib
  • device rotation or extrusion
  • endocarditis
  • extravasation
  • fibrin sheath formation
  • hematoma
  • hemothorax
  • hydrothorax
  • intolerance reaction to implanted device
  • inflammation, necrosis, or scarring of skin over implant area
  • laceration of vessels or viscus
  • perforation of vessels or viscus
  • pneumothorax
  • spontaneous catheter tip malposition or retraction
  • thoracic duct injury
  • thromboembolism
  • vascular thrombosis
  • vessel erosion
  • risks normally associated with local and general anesthesia, surgery, and post-operative recovery

These and other complications are well documented in medical literature and should be carefully considered before placing the port.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Xcela Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Xcela™ Power Injectable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/sec with a 19 G or 20 G non-coring power injectable needle or 2 mL/sec with a 22 G non-coring power injectable needle.

Absolute Contraindications

This device is not designed, sold or intended for use except as indicated.

The port system must not be used in case of:

  • inadequate body tissue to support the device
  • bacteremia
  • sepsis
  • known or suspected allergic response to the materials
  • severe chronic obstructive lung disease exists
  • past irradiation of prospective insertion site
  • previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site local tissue factors will prevent proper device stabilization and/or access

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Xcela Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Xcela™ Power Injectable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/sec with a 19 G or 20 G non-coring power injectable needle or 2 mL/sec with a 22 G non-coring power injectable needle.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

K. Xcela Plus Port, Xcela Plus Port with PASV Valve Technology

1. Full Risk Information 

Indications for Use: The Xcela Plus Port and the Xcela Plus Port with PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the Xcela Plus Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mL/sec with a 19G or 20G non-coring power injectable needle or 2 mL/sec with a 22G non-coring power injectable needle.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Warnings:

  • The device is to be implanted, used, maintained, and removed in strict accordance with institutional and or Centers for Disease Control (CDC) guidelines or policies.
  • During placement through a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism or patient injury may occur. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver.
  • Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity.
  • Do not use syringes smaller than 10 ml when accessing the port as system damage can occur. Flushing occluded catheters with small syringes can create excessive pressures within the port system.
  • Failure to use a power injectable needle with the Xcela Plus Port for a power injection procedure may result in port system failure and patient injury may occur.
  • Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.
  • Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.
  • Failure to warm contrast media to body temperature may result in port system failure and patient injury may occur.
  • Do not exceed 300 psi pressure limit setting or the maximum recommended flow rate setting. Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement and patient injury may occur.
  • If local pain, swelling or signs of extravasation are noted, the injection should be stopped immediately as patient injury may occur.

Adverse Events:

  • Air or Catheter (or Catheter Fragments) Embolism
  • Arteriovenous Fistula
  • Bacteremia
  • Bleeding
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Catheter or Port Erosion through skin/vessel
  • Catheter Occlusion, Malposition, Dislodgment, Fragmentation, Migration, Disconnection or Rupture
  • Catheter Occlusion or Breakage caused by pinching between clavicle and first rib
  • Catheter Thrombosis
  • Death
  • Drug Extravasation
  • Endocarditis
  • Fibrin Sheath Formation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Inflammation
  • Infection
  • Implant rejection
  • Implant rotation or extrusion
  • Implantation site Necrosis or Infection
  • Laceration or Perforation of Vessel
  • Nerve Damage
  • Pneumothorax
  • Risks normally associated with Local and General Anesthesia, Surgery, and Post-operative recovery
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Tunnel infection
  • Vascular Thrombosis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Xcela Plus Port and the Xcela Plus Port with PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the Xcela Plus Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mL/sec with a 19G or 20G non-coring power injectable needle or 2 mL/sec with a 22G non-coring power injectable needle.

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.
  • Presence of infection, bacteremia, septicemia or peritonitis.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Body size is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Xcela Plus Port and the Xcela Plus Port with PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the Xcela Plus Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mL/sec with a 19G or 20G non-coring power injectable needle or 2 mL/sec with a 22G non-coring power injectable needle.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

L. Vaxcel™ Implantable Vascular Access System with PASV Valve Technology

1. Full Risk Information 

Indications for Use: Vaxcel Implantable Port Systems with PASV Valve are indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics,chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

Contraindications:

The device is contraindicated when:

  • The presence of other device related infection, bacteremia, septicemia or peritonitis is known or suspected.
  • Severe chronic obstructive lung disease exists.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors will prevent proper device stabilization and/or access.
  • Anticipation or presence of other central venous intraluminal devices, including pacemakers, is expected.
  • Hypercoagulopathy condition exists, unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device is a potential risk.
  • Body size is insufficient to accommodate size of the portal or the catheter.
  • Demonstrated intolerance for an implanted device.

Venous access to the upper torso may be contraindicated due to anatomical constraints, such as burns to the upper body, cervicothoracic trauma, planned radiation therapy to the mediastinum, bilateral neck dissection and infected median sternotomy incisions.

Warnings:

  • Do not use if package is opened or damaged.

Adverse Events:

  • Air or Catheter (or Catheter Fragments) Embolism

Although Vaxcel™ Implantable Port Systems with PASV™ Valve have been engineered for safety, there are inherent risks associated with any implantable device. These include the following:

  • Air or Catheter Embolism
  • Arteriovenous Fistula
  • Bacteremia
  • Bleeding
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Catheter or Port Erosion through skin/vessel Through Skin/Vessel
  • Catheter Occlusion, Malposition, Dislodgment, Fragmentation, Migration, Disconnection or Rupture
  • Catheter Occlusion or Breakage caused by pinching between clavicle and first rib
  • Catheter Occlusion, Malposition, Dislodgment, Fragmentation, Migration, Disconnection, or Rupture
  • Catheter occlusion or breakage caused by Anesthesia, Surgery, and Post-Operative Recovery pinching between clavicle and first rib
  • Catheter Thrombosis
  • Death
  • Drug Extravasation
  • Endocarditis
  • Embolism of Catheter Fragments
  • Endocarditis
  • Fibrin Sheath Formation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Inflammation
  • Infection
  • Implant rejection
  • Implant rotation or extrusion
  • Implantation site Necrosis or Infection
  • Laceration or Perforation of Vessel
  • Nerve Damage
  • Pneumothorax
  • Risks normally associated with Local and General Anesthesia, Surgery, and Post-operative recovery
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Tunnel infection
  • Vascular Thrombosis

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: Vaxcel Implantable Port Systems with PASV Valve are indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics,chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

Contraindications:

The device is contraindicated when:

  • The presence of other device related infection, bacteremia, septicemia or peritonitis is known or suspected.
  • Severe chronic obstructive lung disease exists.
  •  Past irradiation of prospective insertion site.
  •  Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors will prevent proper device stabilization and/or access.
  • Anticipation or presence of other central venous intraluminal devices, including pacemakers, is expected.
  • Hypercoagulopathy condition exists, unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device is a potential risk.
  • Body size is insufficient to accommodate size of the portal or the catheter.
  • Demonstrated intolerance for an implanted device.

Venous access to the upper torso may be contraindicated due to anatomical constraints, such as burns to the upper body, cervicothoracic trauma, planned radiation therapy to the mediastinum, bilateral neck dissection and infected median sternotomy incisions.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: Vaxcel Implantable Port Systems with PASV Valve are indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics,chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

M. BioFlo Midline with ENDEXO Technology

1. Full Risk Information 

Indications for Use: The BioFlo Midline is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.

Maximum Power Injection Flow Rate

  • 3F Single Lumen/20 cm -2 mL/sec
  • 4F Single Lumen/20 cm - 6 mL/sec
  • 5F Single Lumen/20 cm – 6 mL/sec
  • 5F Dual Lumen/20 cm - 6 mL/sec

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized.
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy.
  • Orthopedic or neurological conditions affecting the extremity.
  • Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site.
  • Anatomical distortion of the veins from surgery, injury or trauma.
  • Inadequate antecubital veins.
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures.

Warnings:

Refer to procedural steps for additional warnings. Due to the risk of exposure to blood borne pathogens, care providers must adhere to guidelines for universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.

  • Do not use if package is opened or damaged.
  • If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
  • Do not fully insert catheter up to suture wing.
  • Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.
  •  Do not re-sheath any needles. Place needles in puncture resistant, leak proof, sharps containers per institutional protocol.
  • Do not attempt to trim the catheter with the guidewire or stylet loaded as catheter, stylet, or guidewire may become damaged resulting in patient injury.
  • Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.
  • Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
  • Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter.
  • Exceeding the maximum allowable flow rate (Table 2) may result in catheter failure and/or catheter tip displacement.
  • Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.
  • The maximum pressure of power injectors used with the power injectable BioFlo Midline must not exceed 325 psi (2,240 kPa).
  • Prior to loading stylet or guidewire cut catheter to desired length. Do not cut catheter while stylet or guidewire is loaded into catheter as device damage or patient injury may occur.
  • Therapies NOT appropriate for BioFlo Midline catheters include those therapies requiring central venous access. Refer to standards of practice and institutional policies.

Potential Complications/Adverse Events:

  • Air Embolism
  • Bleeding
  • Brachial Plexus or other Nerve Injury
  • Catheter Dislodgement
  • Catheter Embolism
  • Catheter Erosion through Skin/Vessel
  • Catheter Fragmentation
  • Catheter Malfunction
  • Catheter Malposition
  • Catheter Migration
  • Catheter Occlusion
  • Catheter Retraction
  • Catheter Rupture
  • Death
  • Drug or Contrast Medium Precipitate
  • Extravasation/Infiltration of Infusate
  • Embolism
  • Endocarditis
  • Exit Site Necrosis
  • Fibrin Sheath Formation
  • Foreign Body Rejection
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Infection
  • Inflammation/Phlebitis
  • Intolerance Reaction to Contrast Media
  • Intolerance Reaction to Implanted Device
  • Malposition
  • Nerve Damage
  • Pain
  • Pleural Effusion
  • Pneumothorax
  • Pulmonary Embolism
  • Renal Compromise
  • Sensitivity or Allergy
  • Sepsis
  • Subintimal Venous or Myocardial Injection
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Vascular Thrombosis
  • Vessel Damage
  • Vessel Stenosis
  • Vessel Tamponade

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The BioFlo Midline is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.

Maximum Power Injection Flow Rate

  • 3F Single Lumen/20 cm -2 mL/sec
  • 4F Single Lumen/20 cm - 6 mL/sec
  • 5F Single Lumen/20 cm – 6 mL/sec
  • 5F Dual Lumen/20 cm - 6 mL/sec

Contraindications:

  • Venous thrombosis in any portion of the vein to be catheterized.
  • Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy.
  • Orthopedic or neurological conditions affecting the extremity.
  • Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site.
  • Anatomical distortion of the veins from surgery, injury or trauma.
  • Inadequate antecubital veins.
  • Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The BioFlo Midline is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.

Maximum Power Injection Flow Rate

  • 3F Single Lumen/20 cm -2 mL/sec
  • 4F Single Lumen/20 cm - 6 mL/sec
  • 5F Single Lumen/20 cm – 6 mL/sec
  • 5F Dual Lumen/20 cm - 6 mL/sec

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

N. Hemodialysis Catheter Repair Kit

1. Full Risk Information 

Indications for Use: To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 4 5cm viable extension tubing

Repairs ANGIODYNAMICS ®Catheters: MORE-FLOW™, DURA-FLOW™, and EVENMORE™

Contraindications:

  • Do not use to repair catheters other than those specified above
  • Do not replace connector if tubing is swollen or displays signs of degradation
  • This repair kit should not be used for any purpose other than indicated in these instructions

Warnings:

  • In the rare event luer connector separates from any component during use, take all necessary steps and precautions to prevent blood loss or air embolism
  • Federal Law (USA) restricts this device to sale by or on the order of a physician
  • This repair kit is for Single Use Only.
  • Do not re-sterilize the repair kit or accessories by any method
  • The manufacturer shall not be liable for any damages caused by reuse or re-sterilization of this repair kit
  • Contents sterile and non-pyrogenic in unopened, undamaged package
  • STERILIZED BY ETHYLENE OXIDE
  • Do not use repair kit if package is opened or damaged
  • Do not use repair kit if any sign of product damage is visible
  • The slide clamp is provided for use during the repair procedure only. DO NOT REUSE the slide clamp as it is not permanently attached and could separate from catheter, resulting in excessive bleeding. Dispose of the slide clamp following the repair procedure
  • Failure to clamp could lead to air embolism or blood loss
  • ALL CATHETER REPAIRS ARE DONE AT THE DISCRETION OF THE ATTENDING PHYSICIAN

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 4 5cm viable extension tubing

Repairs ANGIODYNAMICS ®Catheters: MORE-FLOW™, DURA-FLOW™, and EVENMORE™

Contraindications:

Do not use to repair catheters other than those specified above

Do not replace connector if tubing is swollen or displays signs of degradation

This repair kit should not be used for any purpose other than indicated in these instructions

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 4 5cm viable extension tubing

Repairs ANGIODYNAMICS ®Catheters: MORE-FLOW™, DURA-FLOW™, and EVENMORE™

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

O. PASV™ MS Kit with Pressure Activated Safety Valve

1. Full Risk Information 

Indications for Use: The PASV MS (Modified Seldinger) Kit is designed as a placement kit for PASV PICC catheters. This procedure is indicated for use in establishing peripheral access via the Modified Seldinger technique to the central venous system for administration of intravenous fluids.

NOTE: This instruction is intended as a supplement to the PASV PICC Catheters’ Instructions for Use manual. Please refer to the manual supplied with each catheter for in-depth information.

Contraindications:

The use of PICC catheters is contraindicated in patients with inadequate antecubital veins, pre-existing skin surface or subsurface infection at or near the proposed catheters insertion site, anatomical distortions from surgery, injury or trauma, or anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures.

This kit consists of the following components:

  • Introducer Needle
  • Peel Apart Sheath Dilator Assembly
  • Guidewire
  • Scalpel

Warnings:

Do not use if package is opened or damaged.

The potential for serious complications exists with the insertion and use of any type of central venous catheter. Central venous catheterization should be performed only when potential benefits outweigh the inherent risks of the procedure. The following complications and adverse reactions are well documented in the scientific literature and should be considered before inserting the catheter:

  • Air Embolism
  • Allergic Reaction
  • Bleeding
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Catheter Damage
  • Catheter Embolism
  • Catheter Occlusion
  • Catheter Sepsis
  • Catheter Tip Migration
  • Death
  • Emboli
  • Endocarditis
  • Extravasation
  • Fibrin Formation
  • Hematoma
  • Insertion Site Infection
  • Myocardial Damage
  • Nerve Damage
  • Phlebitis
  • Thromboembolism
  • Tissue Necrosis
  • Vascular Perforation
  • Venous Thrombosis
  • Valvular Injury
  • Vessel Wall Erosion

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The PASV MS (Modified Seldinger) Kit is designed as a placement kit for PASV PICC catheters. This procedure is indicated for use in establishing peripheral access via the Modified Seldinger technique to the central venous system for administration of intravenous fluids.

NOTE: This instruction is intended as a supplement to the PASV PICC Catheters’ Instructions for Use manual. Please refer to the manual supplied with each catheter for in-depth information.

Contraindications:

The use of PICC catheters is contraindicated in patients with inadequate antecubital veins, pre-existing skin surface or subsurface infection at or near the proposed catheters insertion site, anatomical distortions from surgery, injury or trauma, or anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures.

This kit consists of the following components:

  • Introducer Needle
  • Peel Apart Sheath Dilator Assembly
  • Guidewire
  • Scalpel

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The PASV MS (Modified Seldinger) Kit is designed as a placement kit for PASV PICC catheters. This procedure is indicated for use in establishing peripheral access via the Modified Seldinger technique to the central venous system for administration of intravenous fluids.

NOTE: This instruction is intended as a supplement to the PASV PICC Catheters’ Instructions for Use manual. Please refer to the manual supplied with each catheter for in-depth information.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

P. Lifeport Infusion Set

1. Full Risk Information 

Indications for Use: The LifePort Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood.

Contraindications:

Do not use with patients showing signs or symptoms of infection at the insertion site.

Do not use with patients who have exhibited prior intolerance to the materials of construction.

Warnings:

  • Maximum pressure recommended is 40 psi. A 10 ml syringe or larger is recommended.
  • Do not use the device if the package has been opened or damaged.
  • Clamp infusion set when not in use.
  • Store in a cool dry place.
  • Reuse of single-use devices creates a potential risk of patient or user infections.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The LifePort Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood.

Contraindications:

Do not use with patients showing signs or symptoms of infection at the insertion site.

Do not use with patients who have exhibited prior intolerance to the materials of construction.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The LifePort Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Q. Lifeguard Safety Needle

1. Full Risk Information 

Indications for Use: The LifeGuard Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard Safety Infusion Set facilitates the safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.

The LifeGuard 19 and 20 Gauge non Y-Site needles may be used with the AngioDynamics Smart Port CT implantable ports for power injection of contrast media. Maximum pressure recommended for power injection of contrast media is 300 psi and the maximum flow rate is 5 ml/sec. For information and instructions regarding the power injection procedure, please refer to the Instructions for Use Manual for the Smart Port CT Power Injectable Implantable Port Systems.

Contraindications:

Do not use with patients showing signs or symptoms of infection at the insertion site.

Do not use with patients who have exhibited prior intolerance to the materials of construction.

Warnings:

  • Review all fluids to be used with this product for any incompatibility with plastics and plastic adhesives.
  • A 10 ml syringe or larger is recommended.
  • Maximum pressure recommended for power injection of contrast media with the Smart Port CT implantable ports is 300 psi and a maximum flow rate of 5ml/sec. Only LifeGuard 19 and 20 gauge non Y-Site needle models may be utilized for power injection with Smart Port CT.
  • Do not use the device if the package has been opened or damaged.
  • Clamp infusion set when not in use.
  • Store in a cool dry place.
  • Reuse of single-use devices creates a potential risk of patient or user infections.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The LifeGuard Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard Safety Infusion Set facilitates the safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.

The LifeGuard 19 and 20 Gauge non Y-Site needles may be used with the AngioDynamics Smart Port CT implantable ports for power injection of contrast media. Maximum pressure recommended for power injection of contrast media is 300 psi and the maximum flow rate is 5 ml/sec. For information and instructions regarding the power injection procedure, please refer to the Instructions for Use Manual for the Smart Port CT Power Injectable Implantable Port Systems.

Contraindications:

Do not use with patients showing signs or symptoms of infection at the insertion site.

Do not use with patients who have exhibited prior intolerance to the materials of construction.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The LifeGuard Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard Safety Infusion Set facilitates the safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.

The LifeGuard 19 and 20 Gauge non Y-Site needles may be used with the AngioDynamics Smart Port CT implantable ports for power injection of contrast media. Maximum pressure recommended for power injection of contrast media is 300 psi and the maximum flow rate is 5 ml/sec. For information and instructions regarding the power injection procedure, please refer to the Instructions for Use Manual for the Smart Port CT Power Injectable Implantable Port Systems.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

R. 16 Ga Straight Needle High Flow, Non-Coring

1. Full Risk Information 

Warnings:

  • Reuse of single-use devices creates a potential risk of patient or user infections.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

S. Micro Introducer

1. Full Risk Information 

Indications for Use: The micro-introducer is designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needlestick.

Warnings:

Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.

Reprocessing may compromise the integrity of the device and / or lead to device failure.

Potential Complications:

  • Perforation of a vessel or viscus
  • Laceration of a vessel or viscus
  • Extravasation
  • Nerve damage
  • Sterility breach
  • Embolism

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Indications for Use: The micro-introducer is designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needlestick.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

T. Perchik Button

1. Full Risk Information

Indications for Use: The Perchik Button™ is intended to aid wound healing by distributing suture tension over a larger area on the patient.

Potential Complications:

Potential procedural complications include, but are not limited to:

  • Allergic Reaction
  • Bruising
  • Cell Damage
  • Death
  • Drug Reaction
  • Drug Therapy
  • Edema
  • Embolism
  • Fever
  • Hematoma
  • Infection
  • Pain and Tenderness
  • Patient Discomfort
  • Septicemia
  • Surgical Intervention

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Indications for Use: The Perchik Button™ is intended to aid wound healing by distributing suture tension over a larger area on the patient.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

U. EmboSafe™ Valved Peelable Introducer Sheath

1. Full Risk Information 

Indications for Use: The EmboSafe™ Valved Peelable Introducer Sheath is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Contraindications:

The EmboSafe™ Valve Peelable Introducer Sheath is not designed for use in the arterial system or as a hemostatic device.

Potential Complications:

  • Subclavian artery puncture
  • Pneumothorax
  • Hemothorax
  • Air embolism
  • Hematoma formation
  • Brachial plexus injury
  • Subclavian vein thrombosis
  • Wound infection
  • Mediastinal widening

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The EmboSafe™ Valved Peelable Introducer Sheath is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Contraindications:

The EmboSafe™ Valve Peelable Introducer Sheath is not designed for use in the arterial system or as a hemostatic device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The EmboSafe™ Valved Peelable Introducer Sheath is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

V. Vaxcel™ Mini Stick Vascular Entry Kit Coaxial Dilator Set

1. Full Risk Information 

Indications for Use: The coaxial dilator is used for percutaneous introduction of 0.035 in. (0.89 mm) or 0.038 in. (0.97 mm) guidewire into the vascular system following a small 21 Ga. (0.82 mm) needle puncture.

Contraindications: None known.

Warnings:

Do not use if package is opened or damaged.

Adverse Events:

  • Air embolus
  • Bleeding
  • Edema
  • Extravasation
  • Hematoma
  • Inflammation, necrosis or scarring
  • Laceration of a vessel or viscus
  • Pain in region
  • Perforation of a vessel or viscus
  • Skin infection

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The coaxial dilator is used for percutaneous introduction of 0.035 in. (0.89 mm) or 0.038 in. (0.97 mm) guidewire into the vascular system following a small 21 Ga. (0.82 mm) needle puncture.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The coaxial dilator is used for percutaneous introduction of 0.035 in. (0.89 mm) or 0.038 in. (0.97 mm) guidewire into the vascular system following a small 21 Ga. (0.82 mm) needle puncture.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

W. Tearaway Sheath Introducer

1. Full Risk Information

Indications for Use:

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Contraindications:

Use of the introducer is contraindicated if the patient has a known or suspected obstruction in the vessel. There is increased risk of pneumothorax for the patient who has severe chronic lung disease. Poor healing may result in the patient who has had irradiation to the anterior chest.

Warnings:

  • Do not alter this device in any way.
  • Do not use alcohol, acetone or solutions containing these agents. These solutions may affect the properties of the plastic components resulting in degradation of the device.
  • Do not reuse this device.
  • Do not withdraw guidewire through metal needles; guidewire may shear or unravel.
  • Do not resterilize.

Potential Complications:

The potential complications related to the use of the introducer include, but are not limited to the following:

air embolism, wound infection, intimal tear, subclavian artery puncture, pneumothorax, subclavian vein thrombosis, bleeding, cardiac arrhythmia, hematoma formation, hemothorax, hydrothorax, thoracic duct injury, vessel erosion, vessel trauma, thrombosis, brachial artery damage and nerve damage.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Contraindications:

Use of the introducer is contraindicated if the patient has a known or suspected obstruction in the vessel. There is increased risk of pneumothorax for the patient who has severe chronic lung disease. Poor healing may result in the patient who has had irradiation to the anterior chest.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Micro Access Kit

1. Full Risk Information 

Intended Use:

The Micro Access Kit is used for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

Potential Complications:

  • Perforation of a vessel or viscus
  • Laceration of a vessel or viscus
  • Bleeding
  • Hematoma
  • Extravasation
  • Inflammation, necrosis or scarring
  • Pain in region
  • Skin infection
  • Edema

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Intended Use:

The Micro Access Kit is used for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Y. Mini Stick II™ Microintroducer Kit

1. Full Risk Information 

Indications for Use:

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Contraindications:

Use of the introducer is contraindicated if the patient has a known or suspected obstruction in the vessel. There is increased risk of pneumothorax for the patient who has severe chronic lung disease. Poor healing may result in the patient who has had irradiation to the anterior chest.

Warning:

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Navilyst Medical, Inc. representative.

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Complications:

The potential complications related to the use of the introducer include, but are not limited to the following: Air embolism, wound infection, intimal tear, subclavian artery puncture, pneumothorax, subclavian vein thrombosis.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Contraindications:

Use of the introducer is contraindicated if the patient has a known or suspected obstruction in the vessel. There is increased risk of pneumothorax for the patient who has severe chronic lung disease. Poor healing may result in the patient who has had irradiation to the anterior chest.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Z. SafeSheath ULTRALITE

1. Full Risk Information 

Indications for Use: For the introduction of various types of pacing leads and catheters.

Warnings: This product is sensitive to light. Do not use if stored outside the protective outer carton. Store in a cool, dark, and dry place.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Indications for Use: For the introduction of various types of pacing leads and catheters.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

AA. AngioDynamics® Introducer Products

1. Full Risk Information 

Indications for Use: AngioDynamics® Introducers are designed for use during catheterization procedures and are not intended for critical care use.

Warnings:

  • Care should be exercised during insertion, use or removal of the device to prevent aspiration of air into the vasculature.
  • Rapid withdrawal of the catheter or dilator through the hemostasis valve may cause misalignment of the valve gasket assembly, causing bleedback through the valve. Should this occur, resetting of the valve may be accomplished by gentle pressure into the valve with the tip of a dilator or catheter.
  • Inspect the packaging and product for damage prior to use. Do not use if the package is damaged as sterility may be compromised.
  • Care should be taken that acetone solutions or isopropyl alcohol do not come in contact with the introducer hub. Such substances could weaken the hub and cause possible leakage.
  • Tighten all connections prior to use without overtightening. Overtightening can cause damage to the components
  • Periodically check all connections for tightness.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Indications for Use: AngioDynamics® Introducers are designed for use during catheterization procedures and are not intended for critical care use.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

BB. Vaxcel™ Mini Stick Vascular Entry Kit Peelable Introducer Sheath Set

1. Full Risk Information 

Indications for Use:

The Introducer Sheath and Dilator Kit is indicated for use in the percutaneous insertion of catheters following a needle introduction and placement of a guidewire in the venous system.

Contraindications: None known.

Warnings:

Do not use if package is opened or damaged.

Adverse Events:

  • Air embolus
  • Bleeding
  • Edema
  • Extravasation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Inflammation, necrosis or scarring
  • Laceration of a vessel or viscus
  • Pain in region
  • Perforation of a vessel or viscus
  • Pneumothorax
  • Skin infection

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

The Introducer Sheath and Dilator Kit is indicated for use in the percutaneous insertion of catheters following a needle introduction and placement of a guidewire in the venous system.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

The Introducer Sheath and Dilator Kit is indicated for use in the percutaneous insertion of catheters following a needle introduction and placement of a guidewire in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

CC. Vascular Guidewire NITINOL with Hydrophilic Coating

1. Full Risk Information 

Indications for Use: For percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not indicated for use in the coronary or cerebral vasculature.

Warnings:

  • This device is not intended for use in the coronary arteries or the neurovasculature.
  • Reuse of single-use devices creates the potential risk of patient or user infections. Contaminations of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Indications for Use: For percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not indicated for use in the coronary or cerebral vasculature.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

DD. BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter

1. Full Risk Information 

Indications for Use:

  • The BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in adults.
  • Catheters greater than 40 cm are intended for femoral vein insertion.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The presence of other device related infection, bacteremia, or septicemia is known or suspected.
  • Severe chronic obstructive lung disease exists.
  • Past irradiation of prospective insertion site has occurred.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site have occurred.
  • Local tissue factors that will prevent proper device stabilization and/or access.
  • The valved peelable introducer sheaths are not designed for use in the arterial system

Warnings:

  • In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
  • Do not advance the guidewire or catheter if unusual resistance is encountered.
  • Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the introducer needle or sheath introducer and guidewire must be removed together.
  • Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.
  • To avoid air embolism close the valve in the single valved peelable sheath prior to insertion of dilator and remove the guidewire and dilator from the valved peelable sheath immediately after sheath insertion.
  • Do not use acetone on any part of the catheter tubing. Exposure to this agent may cause catheter damage.
  • The catheter should be used with caution and only after careful consideration in patients who are at risk of bleeding complications.

Adverse Events/Potential Complications:

  • Air Embolus
  • Bacteremia
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Central Venous Thrombosis
  • Endocarditis
  • Exit Site Infection
  • Exsanguination
  • Femoral Artery Laceration
  • Femoral Nerve Injury
  • Fibrin Sheath Formation
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Inferior Vena Cava Puncture
  • Inflammation
  • Laceration of the Vessel
  • Lumen Thrombosis
  • Mediastinal Injury
  • Perforation of the Vessel
  • Pleural Injury
  • Pneumothorax
  • Retroperitoneal Bleed
  • Right Atrial Puncture
  • Septicemia
  • Subclavian Artery Puncture
  • Subcutaneous Hematoma
  • Superior Vena Cava Puncture
  • Thoracic Duct Laceration
  • Tunnel Infection
  • Vascular Thrombosis
  • Venous Stenosis
  • Before attempting the insertion, ensure that you are familiar with the above complications and their emergency treatment should any of them occur.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

  • The BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in adults.
  • Catheters greater than 40 cm are intended for femoral vein insertion.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The presence of other device related infection, bacteremia, or septicemia is known or suspected.
  • Severe chronic obstructive lung disease exists.
  • Past irradiation of prospective insertion site has occurred.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site have occurred.
  • Local tissue factors that will prevent proper device stabilization and/or access.
  • The valved peelable introducer sheaths are not designed for use in the arterial system

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

  • The BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in adults.
  • Catheters greater than 40 cm are intended for femoral vein insertion.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

EE. DuraMax Chronic Hemodialysis Catheter

1. Full Risk Information 

Indications for Use:

  • The DuraMax Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • This catheter is indicated for > 30 days long term placement.
  • The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The valved peelable introducer sheath is not designed for use in the arterial system.

Warnings:

  • In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
  • Do not advance the guidewire or catheter if unusual resistance is encountered.
  • Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the introducer needle or sheath introducer and guidewire must be removed together.
  • Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.

Potential Complications:

  • Air Embolus
  • Bacteremia
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Central Venous Thrombosis
  • Endocarditis
  • Exit Site Infection
  • Exsanguination
  • Femoral Artery Bleed
  • Femoral Nerve Damage
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Inferior Vena Cava Puncture
  • Laceration of the Vessel
  • Lumen Thrombosis
  • Mediastinal Injury
  • Perforation of the Vessel
  • Pleural Injury
  • Pneumothorax
  • Retroperitoneal Bleed
  • Right Atrial Puncture
  • Septicemia
  • Subclavian Artery Puncture
  • Subcutaneous Hematoma
  • Superior Vena Cava Puncture
  • Thoracic Duct Laceration
  • Tunnel Infection
  • Vascular Thrombosis
  • Venous Stenosis
  • Before attempting the insertion, ensure that you are familiar with the above complications and their emergency treatment should any of them occur.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

  • The DuraMax Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • This catheter is indicated for > 30 days long term placement.
  • The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The valved peelable introducer sheath is not designed for use in the arterial system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

  • The DuraMax Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • This catheter is indicated for > 30 days long term placement.
  • The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

FF. Dura-Flow™ LONG-TERM HEMODIALYSIS CATHETER with Hydro-Tip® catheter tip

1. Full Risk Information 

Indications for Use:

  • The Dura-Flow™ hemodialysis catheter with Hydro-Tip® catheter tip is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • The curved Dura-Flow™ Catheter is intended for internal jugular vein insertion.
  • Catheters greater than 40cm are intended for femoral vein insertion.
  • The Valved Peelable Introducer Sheath is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The Valved Peelable Introducer Sheath is not designed for use in the arterial system or as a hemostatic device.

Warnings:

  • In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
  • Do not advance the guidewire or catheter if unusual resistance is encountered.
  • Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the introducer needle or Valved Peelable Introducer Sheath and guidewire must be removed together.
  • Federal Law (USA) restricts the device to sale by or on the order of a physician.
  • This catheter is for Single Use Only.
  • Do not re-sterilize the catheter or accessories by any method.
  • Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • The manufacturer shall not be liable for any damages caused by reuse or re-sterilization of this catheter or accessories.
  • Contents sterile and non-pyrogenic in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
  • Do not use catheter or accessories if package is opened or damaged.
  • Do not use catheter or accessories if any sign of product damage is visible.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.
  • Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.

Potential Complications:

  • Air Embolus
  • Bacteremia
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Central Venous Thrombosis
  • Endocarditis
  • Exit Site Infection
  • Exsanguination
  • Femoral Artery Bleed
  • Femoral Nerve Damage
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Inferior Vena Cava Puncture
  • Laceration of the Vessel
  • Lumen Thrombosis
  • Mediastinal Injury
  • Perforation of the Vessel
  • Pleural Injury
  • Pneumothorax
  • Retroperitoneal Bleed
  • Right Atrial Puncture
  • Septicemia
  • Subclavian Artery Puncture
  • Subcutaneous Hematoma
  • Superior Vena Cava Puncture
  • Thoracic Duct Laceration
  • Tunnel Infection
  • Vascular Thrombosis
  • Venous Stenosis
  • Before attempting the insertion, ensure that you are familiar with the above complications and their emergency treatment should any of them occur.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

  • The Dura-Flow™ hemodialysis catheter with Hydro-Tip® catheter tip is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • The curved Dura-Flow™ Catheter is intended for internal jugular vein insertion.
  • Catheters greater than 40cm are intended for femoral vein insertion.
  • The Valved Peelable Introducer Sheath is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The Valved Peelable Introducer Sheath is not designed for use in the arterial system or as a hemostatic device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

  • The Dura-Flow™ hemodialysis catheter with Hydro-Tip® catheter tip is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • The curved Dura-Flow™ Catheter is intended for internal jugular vein insertion.
  • Catheters greater than 40cm are intended for femoral vein insertion.
  • The Valved Peelable Introducer Sheath is intended for use in the percutaneous insertion of catheters in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

GG. DuraFlow™ 2 CHRONIC HEMODIALYSIS CATHETER

1. Full Risk Information 

Indications for Use:

  • The DuraFlow™ 2 Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • This catheter is indicated for > 30 days long term placement.
  • The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The valved peelable introducer sheath is not designed for use in the arterial system.

Warnings:

  • In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
  • Do not advance the guidewire or catheter if unusual resistance is encountered.
  • Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the introducer needle or sheath introducer and guidewire must be removed together.
  • Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.
  • Federal Law (USA) restricts the device to sale by or on the order of a physician.
  • This catheter is for Single Use Only.
  • Do not re-sterilize the catheter or accessories by any method.
  • The manufacturer shall not be liable for any damages caused by reuse or re-sterilization of this catheter or accessories.
  • Contents sterile in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
  • Do not use catheter or accessories if package is opened or damaged.
  • Do not use catheter or accessories if any sign of product damage is visible.
  • Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.

Potential Complications:

  • Air Embolus
  • Bacteremia
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Central Venous Thrombosis
  • Endocarditis
  • Exit Site Infection
  • Exsanguination
  • Femoral Artery Bleed
  • Femoral Nerve Damage
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Inferior Vena Cava Puncture
  • Laceration of the Vessel
  • Lumen Thrombosis
  • Mediastinal Injury
  • Perforation of the Vessel
  • Pleural Injury
  • Pneumothorax
  • Retroperitoneal Bleed
  • Right Atrial Puncture
  • Septicemia
  • Subclavian Artery Puncture
  • Subcutaneous Hematoma
  • Superior Vena Cava Puncture
  • Thoracic Duct Laceration
  • Tunnel Infection
  • Vascular Thrombosis
  • Venous Stenosis
  • Before attempting the insertion, ensure that you are familiar with the above complications and their emergency treatment should any of them occur.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

  • The DuraFlow™ 2 Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • This catheter is indicated for > 30 days long term placement.
  • The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.
  • Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The valved peelable introducer sheath is not designed for use in the arterial system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

  • The DuraFlow™ 2 Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • This catheter is indicated for > 30 days long term placement.
  • The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

HH. EVENMORE® LONGTERM HEMODIALYSIS CATHETER

1. Full Risk Information 

Indications for Use:

  • The EVENMORE® Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • The curved EVENMORE® Catheter is intended for internal jugular vein insertion.
  • Catheters greater than 40cm are intended for femoral vein insertion.
  • This catheter is indicated for a duration not to exceed twelve (12) months.
  • The EmboSafe™ Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The EmboSafe™ introducer is not designed for use in the arterial system or as a hemostatic device.

Warnings:

  • In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.
  • Do not advance the guidewire or catheter if unusual resistance is encountered.
  • Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the introducer needle or sheath introducer and guidewire must be removed together.
  • Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.
  • Federal Law (USA) restricts the device to sale by or on the order of a physician.
  • This catheter is for Single Use Only.
  • Do not re-sterilize the catheter or accessories by any method.
  • The manufacturer shall not be liable for any damages caused by reuse or re-sterilization of this catheter or accessories.
  • Contents sterile in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
  • Do not use catheter or accessories if package is opened or damaged.
  • Do not use catheter or accessories if any sign of product damage is visible.
  • Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.

Potential Complications:

  • Air Embolus
  • Bacteremia
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Central Venous Thrombosis
  • Endocarditis
  • Exit Site Infection
  • Exsanguination
  • Femoral Artery Bleed
  • Femoral Nerve Damage
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Inferior Vena Cava Puncture
  • Laceration of the Vessel
  • Lumen Thrombosis
  • Mediastinal Injury
  • Perforation of the Vessel
  • Pleural Injury
  • Pneumothorax
  • Retroperitoneal Bleed
  • Right Atrial Puncture
  • Septicemia
  • Subclavian Artery Puncture
  • Subcutaneous Hematoma
  • Superior Vena Cava Puncture
  • Thoracic Duct Laceration
  • Tunnel Infection
  • Vascular Thrombosis
  • Venous Stenosis
  • Before attempting the insertion, ensure that you are familiar with the above complications and their emergency treatment should any of them occur.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

  • The EVENMORE® Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • The curved EVENMORE® Catheter is intended for internal jugular vein insertion.
  • Catheters greater than 40cm are intended for femoral vein insertion.
  • This catheter is indicated for a duration not to exceed twelve (12) months.
  • The EmboSafe™ Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Contraindications:

  • The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
  • The EmboSafe™ introducer is not designed for use in the arterial system or as a hemostatic device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

  • The EVENMORE® Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
  • Alternate insertion sites include subclavian vein as required.
  • The curved EVENMORE® Catheter is intended for internal jugular vein insertion.
  • Catheters greater than 40cm are intended for femoral vein insertion.
  • This catheter is indicated for a duration not to exceed twelve (12) months.
  • The EmboSafe™ Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

II. SCHON XL®

1. Full Risk Information 

Indications for Use:

The AngioDynamics® Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inserted into the subclavian or femoral, the internal jugular is the preferred site.

Contraindications:

This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels.

Potential Complications:

  • Air Embolism
  • Bacteremia
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Tamponade
  • Central Venous Thrombosis
  • Endocarditis
  • Exit Site Infection
  • Exsanguination
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Laceration of the Vessel
  • Lumen Thrombosis
  • Mediastinal Injury
  • Perforation of the Vessel
  • Pleural Injury
  • Pneumothorax
  • Retroperitoneal Bleed
  • Right Atrial Puncture
  • Septicemia
  • Subclavian Artery Puncture
  • Subcutaneous Hematoma
  • Superior Vena Cava Puncture
  • Thoracic Duct Laceration
  • Vascular Thrombosis
  • Before attempting the insertion, ensure that you are familiar with the above complications and their emergency treatment should any of them occur.
  • In the rare event that a hub or connector separates from any component during the insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter immediately.
  • Do not advance the stainless steel guidewire or catheter if unusual elastic resistance is encountered. Do not insert or withdraw the guidewire forcibly from any component. The wire could break or unravel, in which case both the catheter and guidewire must be removed simultaneously.
  • Federal law (USA) restricts the device to sale by or on the order of a physician.
  • Single use only. Do not re-sterilize the catheter or accessories by any method. The manufacturer will not be liable for any damages caused by reuse or re-sterilization of the catheter or accessories.
  • Contents sterile and non-pyrogenic in unopened, undamaged package.
  • Sterilized by Ethylene Oxide.
  • Do not use catheter if package is damaged or has been opened. Do not use if catheter or components show signs of damage (crimped, crushed, cut, etc.)

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

The AngioDynamics® Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inserted into the subclavian or femoral, the internal jugular is the preferred site.

Contraindications:

This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

The AngioDynamics® Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inserted into the subclavian or femoral, the internal jugular is the preferred site.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

JJ. FlowGuard Valved Peelable Introducer

1. Full Risk Information 

Indications for Use:

The FlowGuard™ Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Contraindications:

The FlowGuard™ introducer is not designed for use in the arterial system or as a hemostatic device.

Potential Complications:

  • Subclavian artery puncture
  • Inadvertent vessel puncture
  • Thrombosis
  • Pneumothorax
  • Hemothorax
  • Air embolism
  • Hematoma formation
  • Brachial plexus injury
  • Subclavian vein thrombosis
  • Wound infection
  • Mediastinal widening

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use:

The FlowGuard™ Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Contraindications:

The FlowGuard™ introducer is not designed for use in the arterial system or as a hemostatic device.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use:

The FlowGuard™ Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

KK. SmartPort+ and SmartPort Plastic Implantable Ports

1. Full Risk Information

Risk Information

Indications for Use: The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.

Needle Size (G), non-coring power injectableCatheter Size (F)Maximum Recommended Flow Rate Setting (mL/s)Maximum Recommended Pressure Setting (psi)
19/205,6, and 85300
225,6, and 82300

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.2
  • Presence of infection, bacteremia, or septicemia.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Anatomy is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Warnings:

  • The device is to be implanted, used, maintained, and removed in accordance with institutional and/or Centers for Disease Control (CDC) guidelines or policies.
  • During placement through a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism or patient injury may occur. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver.
  • Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity.
  • Do not use syringes smaller than 10 mL syringe when accessing the port as system damage can occur. Flushing occluded catheters with small syringes can create excessive pressures within the port system.
  • Do not forcefully flush the port system with any syringe size. After confirmation of patency by detecting no resistance and the presence of a blood return, use syringes appropriately sized for the medication being injected. Do not transfer the medication to a larger syringe.3
  • Failure to use a power injectable needle with the SmartPort+ or SmartPort Plastic device for a power injection procedure may result in port system failure and patient injury may occur. Refer to the Procedure for Power Injection section in this booklet for additional information and instructions.
  • Failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.
  • Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.
  • Failure to warm contrast media to body temperature may result in port system failure and patient injury may occur.
  • Do not exceed 300 psi (2068 kPa) pressure limit setting or the maximum recommended flow rate setting. Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement and patient injury may occur.
  • If local pain, swelling or signs of extravasation are noted, the injection should be stopped immediately as patient injury may occur.
  • Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, Pinch-Off Syndrome, fibrin formation, thrombosis or malposition. This should be evaluated prior to device usage.
  • A blood return should be present prior to usage of device for any therapy or testing.
  • Do not attempt to measure the patient’s blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.
  • If the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, Pinch-Off Syndrome, thrombosis or malposition. Failure to assess these complaints or observations can lead to device failure.
  • Power injection machine pressure limiting (safety cut-off) settings may not prevent over pressurization of an occluded device.
  • Reuse of single-use devices creates a potential risk of patient or user infections.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.
  • Review all fluids to be used with this product for any incompatibility with plastics or plastic adhesives.

2. Hinke, D.H.; Zandt-Stastny, D.A.; Goodman, L.R.’ et al. Pinch-off Syndrome: A Complication of Implantable Subclavian Venous Access Devices. Radiology 177: 353-356, 1990.

3. Gorski L, Hadaway L, Hagle M, McGoldrick M, Orr M, Doellman D. Infusion Therapy Standards of Practice. Journal of Infusion Nursing. 2016.

Potential Complications:

  • Air or Catheter (or Catheter Fragments) Embolism
  • Allergic Reaction
  • Arterial Puncture
  • Arteriovenous Fistula
  • Bacteremia
  • Bleeding
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Puncture
  • Cardiac Tamponade
  • Catheter or Port Erosion through skin/vessel
  • Catheter Occlusion, Malposition, Dislodgment, Fragmentation, Migration, Disconnection or Rupture
  • Catheter Occlusion or Breakage caused by pinching between clavicle and first rib
  • Catheter Thrombosis
  • Chylothorax
  • Death
  • Drug Extravasation
  • Endocarditis
  • Fibrin Sheath Formation
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Inflammation
  • Infection
  • Implant rejection
  • Implant rotation or extrusion
  • Implantation site Necrosis or scarring of skin over implant area
  • Laceration or Perforation of Vessel
  • Necrosis or scarring over skin implant area
  • Nerve Damage
  • Pain at or around port pocket site
  • Peritonitis
  • Pneumothorax
  • Risks normally associated with Local and General Anesthesia, Surgery, and Post-operative recovery
  • Stuck or difficult to remove catheters
  • Thoracic Duct Injury
  • Thromboembolism
  • Thrombophlebitis
  • Tunnel infection
  • Twiddler’s syndrome
  • Vascular Thrombosis
  • Vessel trauma

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Risk Information

Indications for Use: The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.

Needle Size (G), non-coring power injectableCatheter Size (F)Maximum Recommended Flow Rate Setting (mL/s)Maximum Recommended Pressure Setting (psi)
19/205,6, and 85300
225,6, and 82300

Contraindications:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.2
  • Presence of infection, bacteremia, or septicemia.
  • Past irradiation of prospective insertion site.
  • Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
  • Local tissue factors to prevent proper device stabilization and/or access.
  • Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.
  • Presence or suspicion of allergic reaction to materials contained in this device.
  • Anatomy is insufficient to accommodate size of the port or the catheter.
  • Demonstrated intolerance for an implanted device.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Risk Information

Indications for Use: The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.

Needle Size (G), non-coring power injectableCatheter Size (F)Maximum Recommended Flow Rate Setting (mL/s)Maximum Recommended Pressure Setting (psi)
19/205,6, and 85300
225,6, and 82300

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

LL. C3 Wave

1. Full Risk Information

Risk Information

Indications for Use: The C3 Wave™ System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave™ provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave™ is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:

  • Atrial fibrillation
  • Atrial flutter
  • Severe tachycardia
  • Pacemaker-driven rhythm
  • Chronic obstructive pulmonary disorder (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.

Contraindications: There are no contraindications associated with the C3 Wave™ system. Consult catheter Instructions for Use for Possible Catheter Contraindications.

Warnings:

  • The C3 Wave™ system works with the normal sinus rhythm of the heart. Do not rely on ECG signal detection for catheter tip positioning when interpretation of the external or intravascular ECG P-wave is difficult. For example, when:
  • P-wave is not present
  • P-wave is not identifiable
  • P-wave is intermittent
  • Place ECG adhesive electrodes carefully at locations indicated in these
  • Instructions for Use and ensure good skin-electrode contact. Failure to do so may cause unstable ECG waveforms and/or ECG waveforms that are not described in these Instructions for Use.
  • All components in the accessory pack are single use items. Do not reuse or reprocess.
  • Monitor catheter tip placement during insertion procedure and verify catheter tip location placement using your institutions’ guidelines.
  • Failure to verify catheter placement may result in serious trauma or fatal complications.
  • Inspect package and product prior to use to verify that no damage has occurred during shipping.
  • Reuse or reprocessing may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
  • Reuse or reprocessing may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Risk Information

Indications for Use: The C3 Wave™ System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave™ provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave™ is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:

  • Atrial fibrillation
  • Atrial flutter
  • Severe tachycardia
  • Pacemaker-driven rhythm
  • Chronic obstructive pulmonary disorder (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.

Contraindications: There are no contraindications associated with the C3 Wave™ system. Consult catheter Instructions for Use for Possible Catheter Contraindications.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Risk Information

Indications for Use: The C3 Wave™ System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave™ provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave™ is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:

  • Atrial fibrillation
  • Atrial flutter
  • Severe tachycardia
  • Pacemaker-driven rhythm
  • Chronic obstructive pulmonary disorder (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

MM. Biim Ultrasound System

1. Full Risk Information

Risk Information

Indications for Use: The Biim Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

  • Musculo-skeletal (conventional and superficial)
  • Needle guidance
  • Pediatric
  • Peripheral Vessel
  • Small Organ (breast, thyroid, parathyroid, testicles)

Warnings:

  • Do not use the system for purposes other than those intended and expressly stated by Biim Ultrasound. Operation of the system for unintended purposes or with incompatible devices may lead to harm or serious injury.
  • Do not attempt to modify, remove, override, or otherwise disable any safety devices or features of the Biim Ultrasound Probe or the Biim Ultrasound Application. Interfering with the safety features could lead to harm or serious injury.
  • Users are not allowed to modify this equipment. Changes, modifications, and/or additions to the system should be made only by Biim Ultrasound or by third parties expressly authorized by Biim Ultrasound to do so. Such changes and additions must comply with all applicable laws and regulations that have the force of law within the jurisdictions concerned, and best engineering practices.
  • Do not use the system on products that are not recognized by the Biim Ultrasound Application.
  • Use the Biim Ultrasound System only if you understand its safe and appropriate use.
  • Do not use this device unless you have received appropriate training and understand its operation and capabilities.
  • Only use this device for applications for which you have been trained for safe and effective operation. Do not use this device if you do not know how or doubt your ability to operate the system safely and effectively.
  • Use a legally marketed sterile Probe sheath and sterile gel for clinical applications which contact mucous membranes, non-intact skin, or normally sterile tissue (e.g., biopsy procedures, needle guidance, etc.).
  • Probe sheaths may contain natural rubber latex. Those covers may cause allergic reactions in some individuals. See Section 1.3, “FDA Medical Alert on Latex,” for more information.
  • Use a sterile sheath on the tablet or use another means to maintain sterility during all interactions with the tablet for clinical applications which contact mucous membranes, non-intact skin, or normally sterile tissue (e.g., biopsy procedures, needle guidance, etc.).
  • This device is intended to be used by appropriately trained healthcare professionals.
  • Inspect the Probe, battery and battery charger, and tablet prior to use. Do not use if either device has cracks, chips, or has other visible damage.
  • Do not use the Probe or associated tablet or accessories if any are known to be or suspected of being defective or improperly set up.
  • To prevent injuries or potentially hazardous situations, only use accessories approved or supplied by Biim Ultrasound.
  • Do not use this system in the presence of flammable gases or anesthetics. There are no claims that Biim System is compatible with AP/APG environments as described in IEC 60601-1.
  • Users are responsible for image quality and diagnosis.
  • To avoid the risk of a burn hazard, do not use the transducer with high-frequency surgical equipment. Such a hazard may occur in the event of a defect in the high-frequency surgical neutral electrode connection.
  • Install and use the Biim System according to the electromagnetic compatibility (EMC) guidelines.
  • Users are responsible for following their institutions’ security policies regarding use of wireless devices and interfacing with local networks.
  • The use of portable and mobile radio frequency communications equipment can affect the operation of medical equipment.
  • Do not use if either the Probe or the associated tablet malfunctions.
  • To ensure proper tablet operation, keep the tablet secure.
  • If the Probe or the tablet or any accessories appear to be malfunctioning, stop use immediately.
  • It is recommended to adhere to the ALARA (As Low As Reasonably Achievable) principle to minimize acoustic exposure.

Biim Ultrasound System Compatible Accessories

Warning:

  • To prevent injuries or potentially hazardous situations, only use accessories approved or supplied by Biim Ultrasound.
  • The Biim Ultrasound System is compatible with the following accessories:
  • Battery charger, Biim Ultrasound P001052-01
  • Extra battery, Biim Ultrasound P001050-01
  • Probe holder, Biim Ultrasound P001137-01
  • Tablet*, all of the following tablets are supported:
    • Apple iPad Air 2 or iPad 5th generation
    • Samsung Galaxy Tab S2 or S3
  • Tablet holder* GCX Solutions BIM-0001-60 stand with one of the following tablet enclosures:
    • For Apple iPad Air 2 or iPad 5th generation: ArmorActive Evolve
    • For Samsung Galaxy Tab S2 or S3: PadHoldr FIT GT 9.7
  • Phone*, Apple iPhone 7 Plus is supported for live scanning functions only
  • Sterile sheath for tablet*, Preferred Medical Products IP-1409-S
  • Sterile sheath for Biim Ultrasound Probe*, CIVCO 610-1212 Transducer Cover
  • Ultrasound gel*, Parker Laboratories Aquasonic® 100, Aquasonic Clear®, or SCAN® Ultrasound Gel

*Not manufactured by Biim. For information on how to order Biim compatible accessories, visit the Biim Ultrasound website, biimultrasound.com.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Limited Risk Information

Risk Information

Indications for Use: The Biim Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

  • Musculo-skeletal (conventional and superficial)
  • Needle guidance
  • Pediatric
  • Peripheral Vessel
  • Small Organ (breast, thyroid, parathyroid, testicles)

Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

III. Vascular Interventional Therapies/PAD

A. AngioVac Cannula (Generation 2)

1. Full Risk Information

Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Contraindications:

  • Do not use if the patient has severe arterial or venous vascular disease.
  • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism).
  • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user.
  • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use.
  • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated.
  • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.
  • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques.
  • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device.
  • Do not use in conjunction with a power injector.
  • Do not alter the AngioVac Cannula in any way.

Adverse Events: This device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques. These may occur if the instructions for use are not followed.

Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to:

  • Air Embolism
  • Arrhythmias
  • Blood Loss/Blood Trauma
  • Death
  • Damage to Vessel
  • Device Fracture/Balloon Rupture with Distal Embolization
  • Distal Embolization of Thrombus
  • Hematoma
  • Hemoptysis
  • Hemorrhage
  • Local or Systemic Infections
  • Pleural Effusion
  • Pulmonary Embolism
  • Pulmonary Infarction
  • Vascular Thrombus
  • Venous Valve Injury
  • Ventricular Perforation
  • Vessel Spasm

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Contraindications:

  • Do not use if the patient has severe arterial or venous vascular disease.
  • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism).
  • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

B. AngioVac Cannula C20 and C180 (Generation 3)

1. Full Risk Information

Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Contraindications:

  • Do not use if the patient has severe arterial or venous vascular disease.
  • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism).
  • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user.
  • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use.
  • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated.
  • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.
  • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques.
  • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device.
  • Do not use in conjunction with a power injector.
  • Do not alter the AngioVac Cannula in any way..

Adverse Events: This device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques. These may occur if the instructions for use are not followed.

Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to:

  • Air Embolism
  • Arrhythmias
  • Blood Loss/Blood Trauma
  • Death
  • Damage to Vessel
  • Device Fracture
  • Distal Embolization of Thrombus
  • Hematoma
  • Hemoptysis
  • Hemorrhage
  • Local or Systemic Infections
  • Pleural Effusion
  • Pulmonary Embolism
  • Pulmonary Infarction
  • Vascular Thrombus
  • Venous Valve Injury
  • Ventricular Perforation
  • Vessel Spasm

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Contraindications:

  • Do not use if the patient has severe arterial or venous vascular disease.
  • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism).
  • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

C. AngioVac Circuit

1. Full Risk Information

Indications for Use: The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Contraindications: Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user.
  • Carefully examine the circuit for leaks before and during use. Leakage may result in loss of sterility, blood loss or air embolism. If leakage is observed replace the circuit, the leaking component or tighten the leaking connection.
  • Instructions for use and manuals for all related extracorporeal circulatory devices should be read prior to use, including but not limited to the AngioVac Cannula, centrifugal pump head, control console and bubble trap.
  • As with all medical devices, this device is to be used by or under the direction of trained physicians only.
  • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device.

Adverse Events:

Possible complications include those normally associated with anticoagulation and extracorporeal circulation.

This product, as with all extracorporeal circulatory systems, has possible side effects, which include but are not limited to infections, blood loss/blood trauma, thrombus formation and embolic events. These may occur if the instructions for use are not followed.

Refer to AngioVac Cannula DFU for additional listing of potential adverse events.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Contraindications:

Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

D. VenaCure EVLT 1470 Laser

1. Full Risk Information

Indications for Use: The VenaCure EVLT 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated.

Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Warnings:

  • No modification of this equipment is allowed.
  • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
  • Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided.
  • A Class 4 (IV) Laser is hazardous to the eye from the direct beam and diffuse reflections. It also presents significant skin and fire hazard.
  • Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures, as explained in the rest of this section, in areas where the laser is being used.
  • The aiming beam is a Class 3R (IIIa) laser and an unprotected eye may view the beam scattered from a non-reflective surface. Do not stare into the aiming beam or view it directly with optical instruments.
  • Avoid directing the laser beam anywhere other than the treatment area or calibration ports.
  • Before using a fiber, check it carefully for any signs of damage during storage or transit. Protective caps should be in place over SMA connectors. All screws and ports should be secure. Do not use if there is any sign of damage.
  • There are no user serviceable parts in the VenaCure 1470 laser. The exterior cover should only be removed by a trained and authorized laser service technician.
  • To avoid the risk of electric shock, the equipment must only be connected to a supply main with protective earth.
  • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
  • Always switch off the VenaCure 1470 laser at the rear power switch and disconnect the electrical power cord from the AC supply before performing any of the cleaning or maintenance procedures described below.
  • Extreme caution should be taken when operating the VenaCure 1470 near the eyes.
  • All personnel must wear approved protective glasses to reduce the risk of eye damage. The patient should wear protective glasses.
  • The local Laser Safety Officer should review all procedures for safety prior to system use.
  • All protective glasses should be designed for protection from continuous wave laser radiation in the wavelength range 1440 – 1500 nm.
  • The degree of optical filtration (Optical Density or OD) depends on the application and should be assessed and approved by the appointed Laser Safety Officer for the establishment.
  • The recommendations of European Standards EN 60825-1 or EN 207 are appropriate to assessing laser eye risk. Note that the standards assume a viewing distance from the source of light of more than 100 mm (4 inches).
  • AngioDynamics supplies laser safety glasses marked in accordance with EN 207 as L3 or greater. Contact your local AngioDynamics representative if these are required.
  • The ‘Nominal Ocular Hazard Distance’ is 0.31 m (1 foot).
  • Use of optical accessories and viewing aids, which may increase the eye exposure beyond a safe limit, should be subject to the approval of the Laser Safety Officer.
  • Never look directly into the laser aperture even if wearing safety glasses. Serious eye injury could result.
  • Irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn.
  • Avoid placing reflective materials such as glass, metals and polished plastic in the beam.
  • The VenaCure 1470 laser is not intended for use in oxygen-rich environments. Do not use flammable or explosive anesthetic gases that may be ignited by the laser as the VenaCure 1470 laser is not protected against hazards of ignition of flammable anaesthetic mixtures.
  • As with any conventional surgical operations, adverse reactions may occur following treatment.
  • Use cautiously with patients who have had difficulty with previous laser procedures.

Potential Complications:

Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, DEHP exposure, skin burns and pain.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The VenaCure EVLT 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The VenaCure EVLT 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

E. VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits; and VenaCure EVLT Tre’ Sheath

1. Full Risk Information

Indications for Use: The VenaCure EVLT NeverTouch Procedure Kits, VenaCure EVLT NeverTouch Direct Procedure Kits and the VenaCure EVLT Tre’ Sheath are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremities.

This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Warnings:

  • Treatment of a vein located close to the skin surface may result in skin burn.
  • Paresthesia may occur from thermal damage to adjacent sensory nerves.
  • Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy. Use appropriate eye and protective wear for both patient and operating personnel.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.

Potential Complications:

Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, skin burns and pain.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The VenaCure EVLT NeverTouch Procedure Kits, VenaCure EVLT NeverTouch Direct Procedure Kits and the VenaCure EVLT Tre’ Sheath are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremities.

This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated.

Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The VenaCure EVLT NeverTouch Procedure Kits, VenaCure EVLT NeverTouch Direct Procedure Kits and the VenaCure EVLT Tre’ Sheath are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremities.

This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

F. VenaCure EVLT OPS Procedure Kits

1. Full Risk Information

Indications for Use: The VenaCure EVLT OPS Procedure Kits are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process.
  • Do not use if sterile barrier is damaged. If damage is found, call your sales representative.
  • Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize.
  • Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
  • Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Treatment of a vein located close to the skin surface may result in a skin burn.
  • Paresthesia may occur from thermal damage to adjacent sensory nerves.
  • Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room.
  • Reuse of single-use devices creates a potential risk of patient or user infections.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.
  • Laser protective eyewear must be worn by everyone in the treatment room.
  • Instruct the patient to avoid hot baths and vigorous activity for 7 days following VenaCure EVLT.

Adverse Events:

Potential complications include, but are not limited to the following: Hematoma, Infection, Paresthesia, Phlebitis, Pulmonary Embolism, Skin Burns, Thrombophlebitis, Thrombosis, and Vessel Perforation.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The VenaCure EVLT OPS Procedure Kits are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The VenaCure EVLT OPS Procedure Kits are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

G. VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit (US ONLY)

1. Full Risk Information

Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.

The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Treatment of a vein located close to the skin surface may result in a skin burn.
  • Paresthesia may occur from thermal damage to adjacent sensory nerves.
  • Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room.
  • Prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending. Do not coil the fiber tighter than a radius of 60 mm.
  • The positions of the Site Marks on the EVLT fiber have been matched to the introducer sheath provided in the VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit. Alternative sheaths must not be substituted.
  • Do not tighten the compression clamp on sheath until fiber is in position.
  • Laser protective eye wear must be worn by everyone in the treatment room including the patient.

Adverse Events:

Potential complications include, but are not limited to the following: DEHP Exposure, Deep Venous Thrombus, Hematoma, Hemorrhage, Infection, Necrosis, Neovascularization, Non-Target Irradiation, Paresthesia, Phlebitis, Pulmonary Embolism, Skin Burns and Pain, Infection, Skin Pigmentation Alteration, Thrombophlebitis, Thrombosis, and Vessel Perforation.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.

The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.

The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

H. VenaCure 1470 Pro Laser

1. Full Risk Information

Indications for Use: The VenaCure 1470 Pro laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Warnings:

  • This device is not intended to be used in MR environment.
  • Restrict Access to the working area.
  • All the personnel present in the laser working area must wear all the protective devices.
  • Openings inside installation area that are transparent to laser radiation must be properly darkened.
  • All operators should become familiar with all the requirements for safe use of the medical laser systems as described in CAN/CSA- Z386-14 (Safe use of lasers in health care).
  • Mobile phones and similar electrical devices must be switched off when the laser device is working.
  • To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. The Device shall be installed and used in compliance with the national or local requirements in place in your country.
  • Do not wrap the footswitch with any plastic (or other material) film or cover bag, unless authorized by the manufacturer. The unauthorized use of wrapping bags/films may block the pedal in pressed position and cause unwanted laser emission.
  • If optical fiber is hardly bent or improperly secured, it can lead to damage the fiber and/or harm to the patient or user!
  • For proper use, refer to the Instruction for Use for VenaCure EVLT procedure kits.
  • When selecting a pre-set program, it is a Physician responsibility to check and verify the eligibility of the laser output parameters to the treatment of interest and, in case, to adjust them before proceeding.
  • As with any conventional surgical operations, adverse reactions may occur following treatment. Use cautiously with patients who have had difficulty with previous laser procedures.
  • This operation shall be performed with the device switched off and disconnected from the mains.
  • Use of controls, adjustments or demonstration of procedures other than those specified herein may result in hazardous radiation exposure.

Adverse Events:

Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, DEHP exposure, skin burns and pain.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The VenaCure 1470 Pro laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The VenaCure 1470 Pro laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

I. VenaCure EVLT 400 Micron Fiber Procedure Kit

1. Full Risk Information

Indications for Use: The VenaCure EVLT 400 Micron Fiber Procedure Kit is intended for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous vein, and with veins in the lower limbs with superficial reflux.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process
  • Do not use if sterile barrier is damaged. If damage is found, call your sales representative.
  • Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize.
  • Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
  • Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Treatment of a vein located close to the skin surface may result in a skin burn.
  • Paresthesia may occur from thermal damage to adjacent sensory nerves.
  • Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room.
  • Prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending. Do not coil the fiber tighter than a radius of 60 mm.
  • The positions of the sitemarks on the EVLT fiber have been matched to the introducer sheath provided in the EVLT procedure kit. Alternative sheaths must not be substituted.
  • Do not tighten the compression clamp on sheath until fiber is in position
  • Laser protective eyewear must be worn by everyone in the treatment room including the patient.
  • Instruct the patient to avoid hot baths and vigorous activity for 7 days following VenaCure EVLT procedure.

Adverse Events:

Potential complications include, but are not limited to the following: Hematoma, Skin Burns, Infection, Thrombophlebitis, Paresthesia, Thrombosis, Phlebitis, Vessel Perforation, Pulmonary Embolism

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The VenaCure EVLT 400 Micron Fiber Procedure Kit is intended for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous vein, and with veins in the lower limbs with superficial reflux.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The VenaCure EVLT 400 Micron Fiber Procedure Kit is intended for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the Great Saphenous vein, and with veins in the lower limbs with superficial reflux.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

J. Uni*Fuse Infusion System

1. Full Risk Information

Indications for Use: The UNI*FUSE Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Contraindications: The UNI*FUSE Infusion System is contraindicated for use in the coronary and cerebral vasculature. The UNI*FUSE Infusion System is not intended for the infusion of blood or blood products. Refer to the product insert of the therapeutic solution for indications, contraindications, side effects, cautions and warnings.

Warnings:

  • Single patient use. Do not re-use or resterilize.
  • Do not use if package is damaged.
  • This product should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures.
  • Do not inject contrast medium with a pressure injector if the occluding ball wire is in place.
  • Use an introducer sheath if the puncture is through a synthetic graft.
  • Failure to use an introducer sheath may result in damage to the catheter or occluding ball wire.
  • Reprocessing may compromise the integrity of the device and/or lead to device failures.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Complications may occur, if all the air has not been removed from the infusion catheter and displaced with saline prior to insertion into the body.
  • Never advance the guidewire against resistance; this could cause vessel trauma and/or wire damage. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

Potential Complications:

Potential Complications include, but are not limited to Hematoma at the entry site, Vessel perforation, Vasospasm, Hemorrhage, Contrast extravasation, Embolism, Drug reaction, Allergic reaction to contrast media, Neurological deficits including stroke and death, Pain and tenderness, Vessel dissection, Vascular thrombosis, Other - case (or patient) to which the therapeutic solution is inadequate.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The UNI*FUSE Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Contraindications: The UNI*FUSE Infusion System is contraindicated for use in the coronary and cerebral vasculature. The UNI*FUSE Infusion System is not intended for the infusion of blood or blood products. Refer to the product insert of the therapeutic solution for indications, contraindications, side effects, cautions and warnings.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The UNI*FUSE Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

K. Pulse*Spray Infusion System

1. Full Risk Information

Indications for Use: The PULSE*SPRAY® System, PRO™ Infusion Catheter, and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Contraindications: The PULSE*SPRAY System is contraindicated for use in the coronary and cerebral vasculature. This System is not intended for the infusion of blood or blood products. Refer to product insert of the therapeutic solution of choice for indications, contraindications, side effects, and precautions.

Warnings:

  • The PULSE*SPRAY System, PRO Infusion Catheter, and its related components are supplied sterile and are intended for single use only. Do not re-use or re-sterilize these devices.
  • This System should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures.
  • ANGIODYNAMICS® cannot guarantee the proper function of these components if any component is substituted by those of another manufacturer.
  • Do not inject contrast with power injector, if Occluding Guidewire or Occluding Ball Wire is in place.
  • The use of an introducer sheath is recommended if puncture through a synthetic graft is necessary. Failure to use an introducer sheath may result in damage to the catheter.
  • Reuse of single-use devices creates a potential risk of patient or user infections.
  • Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failures.
  • Complications may occur, if all the air has not been removed from the infusion catheter and displaced with a saline solution prior to insertion into the body.
  • Never advance a guidewire against resistance; this could cause vessel trauma and/or wire damage. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

Potential Complications:

Potential Complications include, but are not limited to Hematoma at the entry site, Vessel perforation, Vasospasm, Hemorrhage, Contrast extravasation, Embolism, Drug reaction, Allergic reaction to contrast media, Neurological deficits including stroke and death, Pain and tenderness, Vessel dissection, Vascular thrombosis, Other - case (or patient) to which the therapeutic solution is inadequate.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The PULSE*SPRAY® System, PRO™ Infusion Catheter, and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Contraindications: The PULSE*SPRAY System is contraindicated for use in the coronary and cerebral vasculature. This System is not intended for the infusion of blood or blood products. Refer to product insert of the therapeutic solution of choice for indications, contraindications, side effects, and precautions.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The PULSE*SPRAY® System, PRO™ Infusion Catheter, and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

L. Nit-Vu Guidewires

1. Full Risk Information

Indications for Use: To facilitate the placement of devices for diagnostic and interventional procedures.

Contraindications: These guidewires are not intended for PTCA use.

Warnings:

  • This device is not intended for use in the coronary arteries or the neurovasculature.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Potential Complications: None known.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: To facilitate the placement of devices for diagnostic and interventional procedures.

Contraindications: These guidewires are not intended for PTCA use.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited 

Risk Information:

Indications for Use: To facilitate the placement of devices for diagnostic and interventional procedures.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

M. Angiographic Guidewires

1. Full Risk Information

Risk Information

Indications for Use: The Navilyst Medical Angiographic Guidewires are intended for use in the percutaneous introduction of catheters

Contraindications: None known.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Navilyst Medical representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
  • Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.
  • If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
  • When advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images. Never position the guidewire blindly, as this may result in misplacement, dissection or perforation.
  • While the guidewire is in a vessel, do not advance the movable core if the tip is in a curved shape. Never twist or force the core because excessive force may cause it to penetrate the coil and damage the vessel.
  • Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation. Resulting guidewire fractures might require additional percutaneous intervention or surgery.
  • Never advance the guidewire against the resistance without first determining the reason for resistance under fluoroscopy. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or vessel damage.

Adverse Events:

  • Angina or unstable angina
  • Arrhythmias
  • Cardiac tamponade/pericardial effusion
  • Cardiogenic shock
  • Coronary artery spasm
  • Death
  • Drug reaction, allergic reaction to contrast medium
  • Embolism (coronary, cerebral)
  • Fractured or entrapped wire requiring surgical removal
  • Hemorrhage or Hematoma
  • Infection, local infection, systemic infection
  • Myocardial ischemia and/or infarction
  • Vascular thrombus
  • Vessel occlusion
  • Vessel trauma (dissection, perforation, rupture or injury)

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Risk Information

Indications for Use: The Navilyst Medical Angiographic Guidewires are intended for use in the percutaneous introduction of catheters.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Risk Information

Indications for Use: The Navilyst Medical Angiographic Guidewires are intended for use in the percutaneous introduction of catheters.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

N. Angiographic Catheters (Soft-Vu, Accu-Vu, Mariner and AngiOptic)

1. Full Risk Information

Indications for Use: AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Contraindications: None known.

Warnings:

  • ANGIODYNAMICS Angiographic Catheters should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures and are not for reuse or resterilization.
  • ANGIODYNAMICS 3 French Angiographic Catheters are not intended for intracranial use.
  • Do not insert catheters directly through synthetic vascular grafts. Insert through a sheath introducer.
  • Never advance or retract an Angiographic Catheter or guidewire against resistance. This may result in damage to the vessel, the product, or both.
  • Do not attempt to hand straighten the tip of any curved tipped catheters which are furnished with a tip straightener. This may result in damage to the product. Tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.
  • Reshaping of the catheter tip is not recommended. Physical damage to the catheter material can result when exposed to heat.
  • Do not leave curved tipped catheters straightened over guidewires for extended periods of time. This will result in failure of the catheter tip to re-form to its intended shape.
  • When using ANGIODYNAMICS HALO Catheters, form or straighten the tip in the distal thoracic aorta using a guidewire when advancing or withdrawing the catheter.
  • Avoid injection of contrast medium into the intercostal and lumbar arteries.
  • Always use a guidewire to remove the catheter from the vasculature. Failure to do so may result in damage to the vessel, puncture site, product, or all three.
  • When retracting catheters, great care must be taken to avoid exerting excessive pressure at the groin entry site. Excessive pressure may result in damage to the vessel, the catheter, or both.
  • The maximum pressure limit of catheters intended for flush angiography is stated on the catheter package. When using a pressure injector, do not exceed the stated maximum pressure.
  • Catheters intended for selective angiography do not have a maximum pressure limit stated on the catheter package. Typical flow rates of up to 10cc per second are stated with pressure generated to achieve these typical flow rates.
  • Flow rates have been established by using a contrast medium as stated on the catheter label at 37° centigrade for a 2 second injection. Since a number of variables (such as media viscosity and temperature) can produce different flow rates, this information should only be used as a guide.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Adverse Events:

Potential complications include, but are not limited to the following: Thrombus formation, Emboli, Arterial wall damage, Plaque dislodgment, Hematoma, Cardiac arrhythmias, Myocardial infarction, Stroke, and Death.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Contraindications: None known.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

O. AURYON Peripheral Atherectomy System

1. Full Risk Information

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Indications for Use: The AURYON™ Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

Contraindications: The use of AURYON™ Atherectomy System is contraindicated where patients are contraindicated for intravascular intervention for PAD.

Warnings:

  • The AURYON™ Atherectomy System is a Class IIb medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the AURYON™ Atherectomy System could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment.
  • The AURYON™ Atherectomy System contains high voltages which are potentially lethal. To avoid electrical shock, do not open the AURYON™ Atherectomy System cover. Internal maintenance of the system must be performed only by personnel from AngioDynamics.
  • Ensure the system is connected to the proper voltage. The voltage rating is marked on the back panel of the laser controller. Operating the system at the incorrect voltage may result in damage to the system units.
  • The system is not intended to be used during a defibrillation event.
  • Skin exposure to laser radiation should be avoided.
  • Possible explosion hazard if the laser is used in the presence of flammable anesthetics or other solutions and gases. The laser beam may ignite solvents of adhesives and flammable solutions. Allow flammable materials to evaporate before the laser is used.
  • Only catheters approved by AngioDynamics are allowed to be used in the AURYON™ Atherectomy System. AngioDynamics supplies sterile fiber optic catheters. Sterility is guaranteed only if the package is unopened, undamaged and before the expiry date.
  • Pay attention when handling the AURYON™ OTW catheter to ensure that the fibers at the distal and proximal ends are not damaged.
  • When moving the AURYON™ Atherectomy System be careful to avoid crashing or sudden impacts. Before moving the system, release the wheels from locking, disconnect the footswitch pedal cable from its connector in the laser system and place the footswitch pedal in the rear storage compartment. After the system is positioned for use, lock the wheels, take out the footswitch pedal from the rear storage compartment, connect the footswitch pedal cable to the laser system and place the footswitch pedal on the floor.

Adverse Events:

As with the use of similar therapies, the following potential complications may occur with the use of this catheter, accessories and adjunctive therapies (Balloon/stent). These complications may include but are not limited to:

  • Serious

    Adverse Events:

    • Death
    • Re-intervention
    • ALI
    • Major amputation
    • Bypass surgery
    • Hematoma with surgery
    • Stroke
  • Procedural Complications:
    • Spasm
    • Major dissection
    • Thrombus
    • Distal embolization
    • Perforation
  • In hospital complications:
    • Re-occlusion
    • Pseudoaneurysm
    • Renal failure
    • Bleeding
  • Other AEs
    • Nerve injury
    • AV fistula formation
    • Infection
    • MI
    • Arrhythmia

2. Abbreviated Risk Information

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Indications for Use: The AURYON™ Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

Contraindications: The use of AURYON™ Atherectomy System is contraindicated where patients are contraindicated for intravascular intervention for PAD.

Warnings:

  • The AURYON™ Atherectomy System is a Class IIb medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the AURYON™ Atherectomy System could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment.
  • The AURYON™ Atherectomy System contains high voltages which are potentially lethal. To avoid electrical shock, do not open the AURYON™ Atherectomy System cover. Internal maintenance of the system must be performed only by personnel from AngioDynamics.
  • Ensure the system is connected to the proper voltage. The voltage rating is marked on the back panel of the laser controller. Operating the system at the incorrect voltage may result in damage to the system units.
  • The system is not intended to be used during a defibrillation event.
  • Skin exposure to laser radiation should be avoided.
  • Possible explosion hazard if the laser is used in the presence of flammable anesthetics or other solutions and gases. The laser beam may ignite solvents of adhesives and flammable solutions. Allow flammable materials to evaporate before the laser is used.
  • Only catheters approved by AngioDynamics are allowed to be used in the AURYON™ Atherectomy System. AngioDynamics supplies sterile fiber optic catheters. Sterility is guaranteed only if the package is unopened, undamaged and before the expiry date.
  • Pay attention when handling the AURYON™ OTW catheter to ensure that the fibers at the distal and proximal ends are not damaged.
  • When moving the AURYON™ Atherectomy System be careful to avoid crashing or sudden impacts. Before moving the system, release the wheels from locking, disconnect the footswitch pedal cable from its connector in the laser system and place the footswitch pedal in the rear storage compartment. After the system is positioned for use, lock the wheels, take out the footswitch pedal from the rear storage compartment, connect the footswitch pedal cable to the laser system and place the footswitch pedal on the floor.

3. Limited Risk Information

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Indications for Use: The AURYON™ Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).

P. Drainage Catheters (Total Abscession)

1. Full Risk Information

Risk Information

Indications for Use: The AngioDynamics Total Abscession General Drainage Catheters are indicated for percutaneous drainage of fluids. This device is not indicated for direct contact with the heart, central circulatory system or the central nervous system.

Contraindications: None known.

Warnings:

  • Do NOT use this catheter with alcohol.
  • Do NOT use this catheter as a delivery system for nutritional supplements.
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Reprocessing may compromise the integrity of the device and / or lead to device failure.

Adverse Events:

  • Biocompatibility reaction
  • Bronchopleural fistula
  • Catheter dislodgment
  • Catheter occlusion
  • Empyema
  • Hemorrhage
  • Locution
  • Pneumothorax
  • Pyopneumothorax
  • Sepsis
  • Skin infection

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Risk Information

Indications for Use: The AngioDynamics Total Abscession General Drainage Catheters are indicated for percutaneous drainage of fluids. This device is not indicated for direct contact with the heart, central circulatory system or the central nervous system.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Risk Information

Indications for Use: The AngioDynamics Total Abscession General Drainage Catheters are indicated for percutaneous drainage of fluids. This device is not indicated for direct contact with the heart, central circulatory system or the central nervous system.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Q. Drainage Catheters (Exodus)

1. Full Risk Information

Risk Information

Indications for Use:

Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Contraindications:

  • Bleeding diathesis
  • Anticoagulant use

Warnings:

  • Do not use catheter for gastrostomy procedures/feeding tubes. Exposure to gastric juices may damage the catheter.
  • Do not place the catheter into the vascular system.
  • Do not expose the catheter to alcohol, as it may damage the hydrophilic coating and the catheter.
  • The Exodus Drainage Catheters have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of Exodus Drainage Catheters in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
  • There is a potential risk of misconnections with connectors from other healthcare applications, such as intravenous equipment, breathing and driving gas systems, urethral/urinary, limb cuff inflation neuraxial devices and other enteral and gastric applications.

Adverse Events:

  • Biloma
  • Bronchopleural fistula
  • Catheter break / fracture
  • Catheter dislodgement
  • Catheter occlusion
  • Cholangitis
  • Empyema
  • Hemorrhage
  • Hematuria
  • Irritation
  • Perforation
  • Peritonitis
  • Pleural effusion
  • Pneumothorax
  • Pyopneumothorax
  • Sepsis
  • Skin infection
  • Urinoma

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Risk Information

Indications for Use:

Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Contraindications:

  • Bleeding diathesis
  • Anticoagulant use

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Risk Information

Indications for Use:

Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Contraindications:

  • Bleeding diathesis
  • Anticoagulant use

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

R. Mini Stick ENVI Non-Vascular Introducer Kit

1. Full Risk Information 

Indications for Use: The Mini Stick™ ENVI Non-Vascular Introducer Kit (and various sterile configurations) is utilized to facilitate the introduction and placement of a 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) diameter guidewire for non-vascular procedures.

Contraindications: None known.

Warning:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Mini Stick™ ENVI Non-Vascular Introducer Kit (and various sterile configurations) is utilized to facilitate the introduction and placement of a 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) diameter guidewire for non-vascular procedures.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Mini Stick™ ENVI Non-Vascular Introducer Kit (and various sterile configurations) is utilized to facilitate the introduction and placement of a 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) diameter guidewire for non-vascular procedures.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

S. Mini Stick Max Coaxial MicroIntroducer Kit

1. Full Risk Information

Risk Information

Indications for Use: The coaxial microintroducer kit is used for the percutaneous introduction of a guidewire into the vascular system.

Contraindications: None known.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Navilyst Medical representative. Inspect prior to use to verify that no damage has occurred in shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
  • Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/ or local government policy.

Adverse Events:

  • Air embolism
  • Hematoma
  • Laceration or perforation of a vessel or viscus
  • Bleeding
  • Infection
  • Pain in region
  • Guidewire shearing, fracture or embolization
  • Inflammation, necrosis or scarring
  • Skin Infection

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Risk Information

Indications for Use: The coaxial microintroducer kit is used for the percutaneous introduction of a guidewire into the vascular system.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Risk Information

Indications for Use: The coaxial microintroducer kit is used for the percutaneous introduction of a guidewire into the vascular system.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

T. Micro-introducer Kits and Accessories

1. Full Risk Information 

Indications for Use: The Micro-introducer Kits are designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needle stick.

Contraindications: None known.

Warning:

  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
  • Reprocessing may compromise the integrity of the device and/or lead to device failure.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

2. Abbreviated Risk Information

Indications for Use: The Micro-introducer Kits are designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needle stick.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

3. Limited Risk Information

Indications for Use: The Micro-introducer Kits are designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needle stick.

Contraindications: None known.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

Rx ONLY or CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.