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Mini Subintimal Tracking and Reentry
PRECAUTIONS: Sharp insertion tools may compromise the integrity of the polymer and/or coating. To avoid guidewire damage and possible shearing of plastic and/or coating, do not withdraw or manipulate the wire through a metal needle cannula. Do not attempt to straighten a wire that has been kinked or bent. Do not advance a kinked guidewire into a balloon catheter, guide catheter, or other interventional device as this may increase the potential of wire breakage. Carefully check and match therapeutic device compatibility to the wire prior to use. Boston Scientific JUDO 1, JUDO 3, JUDO 6, Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires and Boston Scientific Hornet, Hornet 10, and Hornet 14 Guidewires are designed to be compatible exclusively with the Stretch Extension Wire for interventional device exchange. Do not use another extension or exchange system. Excessive tightening of the torque device onto the wire may result in abrasion of the coating on the wire. Catheter exchange should only be done under fluoroscopic control. Do not rotate or manipulate the extended guidewire once it is attached. This may cause the extension wire to detach from the wire.ADVERSE EVENTS: Potential adverse events which may result from the use of the device include but are not limited to: Drug reactions, including allergic reaction to contrast media, Embolism, Hemorrhage or hematoma, including at the access site Infection, local infection, systemic infection, Pain at the access site, Pseudoaneurysm, Vascular thrombus, Vessel spasm, Vessel trauma (dissection, perforation, rupture or injury), possibly requiring surgical repair or intervention. In addition, when used for PTCA: Abrupt closure, Angina or unstable angina, Arrhythmias, Cardiac tamponade/pericardial effusion, Contrast induced renal insufficiency or renal failure, Death, Myocardial infarction or ischemia, Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)Some of the above potential adverse events may require additional surgical intervention.