Cordis OUTBACK® LTD® Re-Entry Catheter

Essential Prescribing Information

Indications

Intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature.

Contraindication

Not intended for use in the coronary or cerebral vasculature.

Warnings

  • Single use only. Do not resterilize.
  • Do not autoclave

Precautions

  • The catheter should only be used by appropriately trained physicians.
  • Do not expose the Catheter to organic solvents (e.g., alcohol).
  • The Catheter should be kept straight during flushing, preparation steps and during guidewire loading. A sterile gauze sponge with heparinized saline maybe used to wipe the catheter going form the proximal hub to the distal tip. Do not tug or otherwise overstretch the catheter to straighten it.
  • Always confirm visualization of the targeted vessel via injection of fluoroscopy before using the catheter. Avoid contrast injection in the sub-intimal space.
  • Minimize sub-intimal dissection tract beyond point of reconstitution.
  • To maintain guidewire position during device exchanges, an exchangeable length guidewire is recommended.
  • Failure to use a recommended guidewire may result in damage to the guidewire, such as, abrasion of the hydrophilic coating, release of polymer fragments, separation of the wire, or inability to withdraw the Catheter over the guidewire.
  • Always visualize tracking of the catheter tip over the femoral-aorta bifurcation.
  • If strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further. Consider using a 3-4mm balloon at low ATM to dilate points of resistance, as needed, along delivery track. If the cause cannot be determined, withdraw the catheter.
  • Excessive rotation, bending or kinking of the Catheter may affect its performance. Withdraw the catheter if it becomes excessively kinked.
  • If the guidewire kinks, carefully attempt to remove the wire and replace with a new one. Stop if any resistance is felt when removing wire from catheter. If resistance is encountered retract the cannula tip back into the shaft and then remove catheter and wire together from vasculature.
  • Excessive calcification at the site of reconstitution may impair performance.

Adverse Events

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

  • Vessel dissection, perforation, or injury
  • Vessel spasm
  • Vascular thrombosis
  • Embolism
  • Pseudoaneurysm

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