INTENDED USE/INDICATIONS FOR USE

The V-18 Control Wire guidewire is available in 110, 150, 200 and 300 cm lengths. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is intended for peripheral use only. A torque device (pin vise) is included with each wire to facilitate directional manipulation of the guidewire. The 110 cm V-18 Control Wire guidewire is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018 in guidewire in hemodialysis AV access procedures. The 150, 200 and 300 cm V-18 Control Wire guidewire are intended for general intravascular use.

CONTRAINDICATIONS

Boston Scientific 110 cm Guidewires are not intended for use in the cerebral vasculature.

PRECAUTIONS

• This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.

Potential adverse events which may result from the use of the device include but are not limited to:

• Air Embolism/Thromboembolism

• Allergic Reaction

• Amputation

• Arteriovenous (AV) Fistula

• Death

• Embolism

• Hematoma

• Hemorrhage

• Hemoglobinuria

• Infection or Sepsis/Infection

• Myocardial Ischemia and/or Infarction

• Pseudoaneurysm

• Stroke (CVA)/Transient Ischemic Attacks (TIA)

• Thrombus

• Vessel Occlusion

• Vessel Perforation, Dissection, Trauma or Damage

• Vessel Spasm

• Wire Entrapment/Entanglement

• Foreign Body/Wire Fracture