Indications For Use
The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.
The ELITECROSS™ Support Catheter is not intended for use in the cerebral or coronary vasculature.
- Sterile. Sterilized with ethylene oxide gas. Nonpyrogenic. For Single use. Do not resterilize.
- This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use. Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.
- Do not manipulate catheter through a metal sheath as it may result in damage and/or separation of the hydrophilic coating requiring retrieval.
- Do not advance or torque the catheter in the vascular system or into a stenotic lesion (chronic total occlusion) unless the distal end is supported by an ancillary device.
- Do not use with Ethiodol or Lipiodol* contrast media, or other such contrast media which incorporates the components of these agents.
- Do not expose to organic solvents (e.g., alcohol).
- Do not exceed maximum pressure rating printed on product label.
- If damage is detected in the catheter at any time, replace with an undamaged catheter.
- Store in a cool, dark, dry place.
- Do not use if package is opened or damaged.
- Use prior to the “Use By” date.
- Exposure to temperatures above 60°C (140°F) may damage the catheter.
- The catheter should only be used by physicians trained in percutaneous interventional techniques in a fully equipped catheterization laboratory.
- Do not use without completely reading and understanding this document.
- To prevent damage to the catheter during removal from the package, grasp the hub and withdraw the catheter.
- Inspect the catheter before use to verify that its size, shape and condition are suitable for the specific procedure.
- If strong resistance is met during manipulation, determine the cause of resistance before proceeding.
- Torquing the catheter excessively may cause damage to the product and/or, specifically, result in possible separation along the catheter shaft.
- Withdraw the catheter if it becomes kinked, or if binding occurs between the catheter and ancillary device.
- 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.
- Advancement, manipulation and withdrawal of the catheter should always be performed under fluoroscopic guidance.
This product is designed for use by physicians trained in and familiar with percutaneous interventional
Please refer to the Instructions For Use for complete information.