Cordis catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
- Discard catheters 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.
- 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.
- Store in a cool, dark, dry place.
- Do not use if package is open or damaged.
- Do not use the catheter if the “Use By” date on the package label has expired.
- Do not resterilize.
- Exposure to temperatures above 54°C (130°F)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® pigtail catheters:
- 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.
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 the following:
- air embolism
- hematoma at the puncture site
- perforation of the vessel wall
Please refer to the Instructions For Use for complete information, including indications, precautions, warnings, and potential adverse events.