Indications, safety, and warnings for Thruway™ Guidewire .014" & .018"

INTENDED USE/INDICATIONS FOR USE

The Thruway Guidewire facilitates placement of a catheter during diagnostic or interventional peripheral intravascular procedures including but not limited to renal intervention. The wire can be torqued to facilitate navigation throughthe vasculature.

CONTRAINDICATIONS

• Not intended for use in coronary arteries
• Not intended for use in the neurovasculature

WARNINGS

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damageis found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse,reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failurewhich, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create arisk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, thetransmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Attention should be paid to guidewire movement in the vessel. Before a wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a wire without observing corresponding movement of the tip. Always advance or withdraw a wire slowly. Never push, auger, or withdraw a guidewire which meets resistance or the guidewire may perforate the vessel if forced against resistance. Resistance may be felt tactilely or noted by tip buckling during fluoroscopy. Do not continue advancing if vessel resistance is met (especially in the renal vasculature)as this could cause vessel perforation

When reintroducing a guidewire into a catheter within the vessel, confirm that the catheter tip is free within the lumen(i.e., not against the vessel wall) as this could cause vessel perforation.

PRECAUTIONS

Free movement of the guidewire within a catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information. Test the system for any resistance prior to use.

Excessive tightening of the torque device onto the wire may result in abrasion of the coating on the wire. Do not torque, advance or withdraw the guidewire if significant resistance is felt. Torqueing, advancing or withdrawing a guidewire against significant resistance may cause vessel damage, guidewire damage and/or guidewire tip separation.

POTENTIAL ADVERSE EVENTS

The complications that may result from the use of a guidewire in a procedure include:

• Vessel perforation, dissection, trauma or damage
• Embolism
• Hematoma
• Infection
• Vessel spasm
• Hemorrhage
• Renal Failure
• Myocardial Infraction
• Vascular thrombosis
• Stroke
• Death

This device should be used only by physicians with a thorough understanding of angiography and percutaneousinterventional procedures.

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INTENDED USE/INDICATIONS FOR USE

The Thruway™ Guidewire facilitates placement of a catheter during diagnostic or interventional peripheral intravascular procedures including but not limited to renal intervention. The wire can be torqued to facilitate navigation through the vasculature.

CONTRAINDICATIONS

• Not intended for use in coronary arteries
• Not intended for use in the neurovasculature

WARNINGS

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damageis found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create arisk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Free movement of the guidewire within a catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information. Test the system for any resistance prior to use.

Attention should be paid to guidewire movement in the vessel. Before a wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a wire without observing corresponding movement of the tip. Always advance or withdraw a wire slowly. Never push, auger, or withdraw a guidewire which meets resistance orthe guidewire may perforate the vessel if forced against resistance. Resistance may be felt tactilely or noted by tip buckling during fluoroscopy. Do not continue advancing if vessel resistance is met (especially in the renal vasculature)as this could cause vessel perforation.

When reintroducing a guidewire into a catheter within the vessel, confirm that the catheter tip is free within the lumen(i.e., not against the vessel wall).

PRECAUTIONS

Carefully read all instructions prior to use of this product. Observe all warnings and precautions, failure to do so may result in complications. 

This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.

POTENTIAL ADVERSE EVENTS

The complications that may result from the use of a guidewire in a procedure include:

• Vessel perforation, dissection, trauma or damage
• Embolism
• Hematoma
• Infection
• Vessel spasm
• Hemorrhage
• Renal Failure
• Myocardial Infraction
• Vascular thrombosis
• Stroke
• Death

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