Cordis SLEEK® RX PTA Dilatation Catheters

Essential Prescribing Information

Indications

The Cordis SLEEK® RX PTA Dilatation Catheter is intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.

Contraindication

  • Contraindicated for use in 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 potential inability to withdraw the catheter through the introducer sheath.
  • In PTA, the dilated balloon should not markedly exceed the diameter of the vessel lying just proximal to the stenosis.
  • Use only an endoflator or 20ml syringe for inflation.
  • 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

  • Dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
  • For use only by appropriately trained physicians.
  • 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 unit and withdrawing both together, using a gently twisting motion combined with traction.
  • Before removing catheter from sheath it is very important that the balloon is completely deflated.
  • Proper 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:
    • 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

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