Fathom® Steerable Guidewire

Prescriptive Information

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Refer to the Instructions for Use for complete instructions for use.

Indications

The FATHOM .016" Steerable Guidewire family is intended for general intravascular use including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Contraindications

This guidewire is not intended for use in the coronary vasculature.

Warnings

Before a guidewire is advanced or withdrawn, verify tip movement under fluoroscopy to prevent the possibility of vessel perforation or guidewire damage. Do not torque a guidewire without observing corresponding movement of the distal guidewire tip; otherwise, guidewire damage, such as tip separation, and/or vessel trauma may occur.

Always advance or withdraw the guidewire slowly and carefully. Never advance, auger, withdraw, or torque a guidewire which meets resistance. Resistance may be felt and/or observed under fluoroscopy by noting any buckling or prolapse of the guidewire tip. Excessive force against resistance may result in damage to the guidewire, such as separation of the guidewire tip, damage to the interventional device, and/or vessel perforation. Determine the cause of the resistance under fluoroscopy and take any necessary remedial action.

The torque device and the introducer and are not intended to enter the patient's body.

Potential Adverse Effects

Please notify your Boston Scientific representative immediately by telephone or FAX if a device malfunctions or patient complication or injury is experienced or suspected associated with the use of this device. Please make every attempt to retain any suspect device, its associated components and their packaging for return to Boston Scientific.

As with all guidewires used in interventional procedures, potential complications include, but are not limited to: hematoma at the site of entry, emboli, hemorrhage, ischemia, vasospasm, and neurological deficits including stroke and death.

Cautions

• Confirm the compatibility of the guidewire diameter with the interventional device before actual use. Fathom .016" Steerable Guidewire/0.016" (0.41mm) Maximum Distal Outside Diameter/0.016" (0.41mm) Maximum Proximal Outside Diameter/Compatible Microcatheters: Microcatheters with ID .021-.027" e.g. Renegade® Hi-Flo Microcatheter, Renegade Fiber Braided Microcatheter, Renegade STC-18 Microcatheter.
• If other interventional devices are used with the Fathom .016" Steerable Guidewire, then refer to that product labeling for intended use, contraindications and potential complications associated with the use of that interventional device. Verify that package integrity has not been compromised prior to use. Do not use a product after the expiration date.
• Inspect the guidewire for any visible damage prior to use. Do not use a guidewire that is damaged.
• Carefully examine all equipment for defects prior to the interventional procedure. Do not use any defective equipment.
• Confirm the compatibility of the guidewire with the microcatheter before use. The wire should move freely within the catheter.
• It is recommended that a continuous saline flush be maintained between the guiding catheter and the interventional device and between the interventional device and the guidewire during the procedure. Flushing prevents contrast crystal formation and/or clotting on the guidewire and in the catheter lumen.