Cordis AQUATRACK™ Hydrophilic Guidewire

Essential Prescribing Information

Indications

The Cordis AQUATRACK™ Hydrophilic Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.

Contraindications

None Known.

Warnings

  • AQUATRACK™ Hydrophilic Steerable Guidewires have not been tested for safety under MRI and in MRI guided interventions and therefore are not recommended for use under MRI.
  • Do not reuse. Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. All parts are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused. Cordis Corporation will not be responsible for any direct, incidental or consequential damages resulting from reuse of the product.
  • Guidewires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guidewire carefully for bends, or kinks. Do not use a guidewire that shows signs of damage. Damage will prevent the guidewire from performing with accurate torque response and control.
  • Guidewire manipulation/torquing should always be performed under fluoroscopic guidance.
  • Never advance, withdraw or auger the guidewire against resistance without first determining the cause of resistance under fluoroscopy. Torquing the guidewire against resistance may cause damage and/or fracture which may result in separation of the distal tip.
  • Should the guidewire tip become entrapped within the vasculature (e.g. small side branch, tight stenosis), DO NOT TORQUE THE GUIDEWIRE. Advance the catheter distally, gently pull the guidewire back into the catheter, and remove the catheter/guidewire system as a unit.
  • Should torque control/tip response be compromised during use, confirm tip integrity using fluoroscopy. LOSS OF TORQUE CONTROL MAY BE DUE TO CORE WIRE FRACTURE. Under fluoroscopic guidance, advance the catheter to the distal end of the guidewire and remove the catheter/guidewire system as a unit.

Precautions

  • Store in a cool, dark, dry place.
  • Do not use open or damaged packages.
  • Use prior to the “Use By” date.
  • Do not resterilize.
  • Do not expose to organic solvents.
  • Do not use a metal torque device or metal insertion tool on a hydrophilic guidewire. This may damage and/or compromise the integrity of the coating. If difficulty in grasping the wire is experienced due to the lubricious surface of the wire, the plastic torque device provided with the product may be used.

Adverse Events

  • Procedures requiring percutaneous guidewire introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at anytime during or after the procedure.
  • Possible complications include, but are not limited to:
    • Air embolism
    • Hematoma at the puncture site
    • Infection
    • Perforation of the vessel wall

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.