SENTAI™ Guidewires - Indications, Safety and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

Boston Scientific JUDO 1, JUDO 3, JUDO 6, Fighter, Marvel, Samurai, and Samurai RC, and Hornet, Hornet 10, and Hornet 14 Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature. Attachment of the Stretch Extension Wire to a Boston Scientific extendable guidewire creates an extended guidewire that can be used to exchange out a percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) catheter without removing the original guidewire from the artery. When the exchange is complete, the Stretch Extension Wire can be detached and the original guidewire can be used in a conventional manner.

CONTRAINDICATIONS

None known.

WARNINGS

Guidewires should be used only by physicians thoroughly trained in their intended use. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Severe reaction may occur in response to contrast agents that cannot be adequately premedicated.

Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or vessel damage.

Resulting guidewire fractures might require additional percutaneous intervention or surgery.

The hydrophilic coating of these guidewires increases the possibility of vessel wall perforation compared to non- hydrophilic coatings. Care should be taken when advancing a guidewire after stent deployment. A guidewire may exit between stent struts when recrossing a stent that is not fully apposed to the vessel wall. Subsequent advancement of any device over the guidewire could cause entanglement between the guidewire and the stent.

JUDO 3, JUDO 6, Hornet 10 and Hornet 14 Guidewires have stiff distal ends. Operate these guidewires carefully so as not to injure the blood vessel, based on information in these instructions. The higher torque performance, stiffer distal end, and/or increased advancement force may present a higher risk of perforation or injury than if using a more flexible guidewire.

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.

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