Cordis INFINITI® Diagnostic Catheter

Essential Prescribing Information

Indication

Designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Contraindication

None Known.

Warnings

  • Do not reuse.
  • Do not expose to organic solvents.
  • Do not use with Ethiodol* or Lipiodol* contrast media, or other such contrast media which incorporates the components of these agents.
  • Do not exceed maximum pressure rating printed on product label and hub.

Precautions

  • Do not resterilize.
  • Do not autoclave. Exposure to temperatures above 54ºC (130ºF) may damage the catheter.
  • To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.
  • Exercise care when removing guidewires from multiple-curve catheters.
  • To prevent kinking of 5F (1.65 mm) and smaller angiographic catheters, and specifically the 4F (1.35 mm) INFINITI® Catheters (Pigtail):
    • Straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener. Do not straighten by hand.
    • Use a guidewire when introducing the catheter through the catheter sheath introducer (CSI) and into the left ventricle.
  • Treat all 4F (1.35 mm) catheters and smaller French sizes with ultimate care. The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.
  • Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.
  • Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.
  • Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.

Adverse Events

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

Important Information:
Prior to use, refer to the “Instruction for Use” supplied with these devices for indications, contraindications, adverse events, suggested procedure, warnings and precautions.

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

*The third-party trademarks used herein are trademarks of their respective owners.