Cordis SLEEK® OTW PTA Dilatation Catheters

Essential Prescribing Information

Indications

The Cordis SLEEK® OTW PTA Dilatation Catheter is intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries. Any use for procedures other than those indicated in the Instructions For Use is not recommended.

These catheters are not designed to be used in the coronary arteries.

Warnings

  • For single use only. DO NOT resterilize and/or reuse.
  • To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.
  • CAUTION: Do not exceed the rated burst pressure. A syringe with pressure gauge is recommended to monitor pressure. Pressure in excess of the rated burst pressure can cause balloon rupture and potentially inability to withdrawal the catheter through the introducer sheath.
  • Use a 20ml or larger syringe for inflation.
  • Use the catheter prior to the “Use By” date specified on the package.
  • Do not advance the guidewire, balloon dilatation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.
  • This catheter is not recommended for pressure measurement or fluid injection.

Precautions

  • Dilatation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
  • The sealed catheter container should be inspected prior to opening. If the seal is broken or the container has been damaged or wet, sterility cannot be assured.
  • Careful attention must be paid to the maintenance of tight catheter connections to avoid the introduction of air into the system.
  • If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and sheath as a unity and withdrawing both together, using a gently twisting motion combined with traction.
  • Before removing catheter from sheath it very important that the balloon is completely deflated.
  • Properly functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter.

Adverse Events

Possible adverse events include, but are not limited to, the following:

  • Vessel perforation
  • Vessel spasm
  • Hemorrhage
  • Hematoma
  • Hypotension
  • Pain and tenderness
  • Arrhythmias
  • Sepsis/infection
  • Systemic embolization
  • Endocarditis
  • Short-term hemodynamic deterioration
  • Death
  • Vascular thrombosis
  • Drug reactions, allergic reaction to contrast media
  • Pyrogenic reaction
  • Arteriovenous fistula
  • Thromboembolic episodes
  • Vessel dissection
  • Potential balloon separation following rupture or abuse and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.

Important Information

Prior to use, refer to the full “Instructions for Use” supplied with these devices for more information on indications, contraindications, suggested procedures, warnings and precautions.

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