V-18™ & V-14™ ControlWire™ Guidewire

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.

INTENDED USE/INDICATIONS FOR USE

The V-18 Control Wire Guidewire with ICE Hydrophilic Coating is available in 110 cm, 150 cm, 200- cm 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 with ICE Hydrophilic Coating is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018 in (≤ 0.47 mm) guidewire in hemodialysis AV access procedures.
The 150 cm, 200 cm and 300 cm V-18 Control Wire Guidewire ICE Hydrophilic Coating are intended for general intravascular use.
 

CONTRAINDICATIONS

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

WARNINGS

• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.
• The hydrophilic coating of these guidewires increases the possibility of vessel trauma compared to guidewires without hydrophilic coatings. Maintain control of the distal tip at all times during an intervention to avoid vessel trauma.
   

PRECAUTIONS

• Abrasion of the hydrophilic coating may be caused by a tight catheter. Use of incompatible devices may result in damage to the guidewire or hydrophilic coating. If coating is damaged or any resistance is felt during introduction of the catheter, exchange the guidewire and the catheter.
   

ADVERSE EVENTS

Potential adverse events which may be associated with the use of the device during an endovascular procedure when used as indicated include, but are not limited to:

• Allergic Reaction
• Bleeding/Hemorrhage
• Cerebrovascular accident (CVA), Transient Ischemic Attack (TIA)
• Death
• Embolism (air, device, plaque, thrombus, tissue, or other
• Hematoma
• Infection/Sepsis
• Myocardial Infarction/Ischemia
• Need for additional intervention or surgery
• Pain/discomfort
• Renal insufficiency or renal failure
• Thrombosis/Thrombus
• Vasospasm
• Vessel Occlusion
• Vessel trauma (AV fistula, dissection, perforation, pseudoaneurysm, rupture or injury)