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V-18™ & V-14™ ControlWire™ Guidewire

Indications, Safety and Warnings

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Prescriptive Information

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.

V-14 ControlWire Guidewire wICE Coating

INTENDED USE/INDICATIONS FOR USE

Boston Scientific V-14™ ControlWire® Guidewire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewire is not intended for use in the cerebral vasculature. The devices are provided nonpyrogenic, sterile, and intended for one procedure only.

CONTRAINDICATIONS

None known.

WARNINGS

The V-14 ControlWire Guidewires should be used only by physicians trained in angiography and PTA. Vessel trauma may result from the improper use of this device.

ADVERSE EVENTS

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

• Allergic reaction

• Contrast induced renal insufficiency or renal failure

• Death

• Embolism

• Hematoma at the puncture site

• Hemorrhage

• Infection

• Pseudoaneurysm

• Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)

• Vascular thrombus

• Vessel spasm

• Vessel trauma (dissection, perforation, rupture or injury)

Some of the above potential adverse events may require additional surgical intervention.

V-18 Control Wire Guidewire wICE Coating

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.

 

ADVERSE EVENTS

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

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