The CrossBoss Catheter is intended for use with a guidewire to access discrete regions of the coronary vasculature. When used as part of the BridgePoint Medical System (consisting of the CrossBoss Catheter, Stingray™ Orienting Balloon Catheter “Stingray Catheter”, and Stingray Guidewire), the CrossBoss Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
Do not use with guidewire extension systems with a coupling profile larger than 0.014” (0.36mm) diameter (i.e. wave pattern coupling mechanism).
Only physicians thoroughly trained in interventional procedures should use the CrossBoss Catheter.
Do not use CrossBoss Catheter if package is open and sterile barrier is broken.
To reduce the potential for vessel damage, the CrossBoss Catheter should only be used in vessels that are ≥ 1 mm in diameter.
Always use the included torque device during catheter advancement and manipulation especially during device rotation. Failure to use the included torque device may result in catheter failure and may result in patient injury.
The CrossBoss Catheter is intended for single procedure use only. Do not attempt to reuse or re-sterilize as this may increase the risk of compromised device performance, cross contamination or patient injury.
In coronary applications, the CrossBoss Catheter should only be used in hospitals where emergency coronary bypass surgery can be immediately performed in the event of a potentially injurious or life threatening complication.
Before insertion of the CrossBoss Catheter, administer appropriate anticoagulant and vasodilator therapy.
The CrossBoss Catheter should be handled with care. Prior to use and during the procedure, inspect the packaging and catheter for bends, kinks, or other damage. Discontinue use if the catheter becomes damaged.
Do not expose to organic solvents.
The CrossBoss Catheter should only be manipulated under fluoroscopic observation.
Do not use a syringe smaller than 5cc when flushing the catheter.
Do not use an inflation or power assist device when flushing the catheter.
Potential adverse events include, but are not limited to, the following: Acute myocardial infarction, allergic reaction to contrast media, Arterial Perforation(Surgery required), Artery spasm, Bleeding from catheter the insertion point, Blood Toxicity, Bruising at the catheter insertion point, Chest discomfort, Death, Deterioration of kidney function/kidney failure, Dissection or thrombosis with vessel occlusion, Drug reactions, Embolism, Fever, Hematoma at catheter insertion point, Hemorrhage or hematoma, Infection, Infection at skin puncture site, Ischemia due to restenosis of the dilated segment, Myocardial infarction with release of CK-MB into circulation, Neurological deficit, Occlusion of a branch of coronary artery, Prolonged procedure time, Provocation of heart attack/stroke Recurrence of angina, Stroke, Surgery to recover failed devices, Surgery to repair a failed procedure, Ventricular failure, Vessel trauma requiring surgical repair or intervention, Toxicological response, When failures of PTCA occur, they are often treated using coronary artery bypass surgery