OffRoad™ Re-entry Catheter System
Indications, Safety, and Warnings
INTENDED USE/INDICATIONS FOR USE
The OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions.
Contraindicated for use in the coronary, cerebral and carotid arteries.
- Do not advance the guidewire, the Positioning Balloon Catheter, Micro-Catheter Lancet, or any other component if resistance is met.
- Do not use a 0.014 in (0.36 mm) guidewire that has a polymer (plastic) cover/sleeve with the Micro- Catheter Lancet.
- If using a 0.014 in (0.36 mm) PTFE coated guidewire, do not manipulate the PTFE coated part of the wire (i.e. back-and-forth movements) beyond the tip of the Micro-Catheter Lancet.
- Using an inappropriate guidewire may result in damage to the guidewire such as abrasion of the coating, release of polymer fragments or separation of the guidewire.
- Do not exceed the rated balloon burst pressure.
- Use an inflation device with a pressure gauge for accurate balloon inflation/deflation.
- Use only the recommended balloon inflation medium (50/50 solution of saline and contrast medium). Never use air or any gaseous medium to inflate the balloon.
- 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, sterility cannot be assured.
- Careful attention must be paid to maintain tight catheter connections and aspiration before proceeding to avoid air introduction into the system.
- Before removing the catheter from the sheath, it is important that the balloon is completely deflated.
- Caution: The catheter system should not be advanced against resistance. The cause of the resistance should be identified and corrective action should be taken. If resistance is felt upon catheter removal from an artery, then the system, guidewire, and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is suspected.
- Damage may result from kinking, stretching, or forcefully wiping either catheter. Care should be used when handling.
- The OffRoad Re-Entry Catheter System is not intended for injection of contrast medium into the vessel.
- Excessive calcification at the site of re-entry may impair performance.
Complications that may result from endovascular procedures include, but are not limited to:
- Allergic reaction (device, contrast medium and medications)
- Arteriovenous fistula
- Embolization; air, device, plaque, etc.
- Hemorrhage, including bleeding at the puncture site
- Thromboembolic episodes
- Vessel injury, e.g. dissection, perforation, rupture
- Vessel occlusion
- Vessel spasm