COOK Medical TriForce Instrucciones De Uso página 3

TRIFORCE™ PERIPHERAL CROSSING SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The TriForce Peripheral Crossing Set combines the CXI Support Catheter and
Flexor® technology in one device. The set includes three components: An
outer 5.0 French Flexor sheath with radiopaque tip and hydrophilic coating,
an inner 4.0 French CXI Support Catheter, and a Peel-Away® sheath. The outer
Flexor sheath is tapered down to a 4.0 French inner diameter at the tip to
ensure smooth transition to the CXI Support Catheter. This set is compatible
with a 0.035" wire guide.
INTENDED USE
The TriForce Peripheral Crossing Set is intended to be percutaneously
introduced into blood vessels and support a wire guide while performing
percutaneous peripheral interventions. This device is also intended for
injection of radiopaque contrast media for the purpose of angiography.
CONTRAINDICATIONS
None known
WARNINGS
• Avoid introducing air or any other gas through the catheter into the
vascular system.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
percutaneous peripheral interventions. Standard techniques for placement
of vascular access sheaths, angiographic catheters, and wire guides should
be employed.
• The device is designed and intended for one time use only. Do not
re-sterilize and/or reuse.
• Device manipulation should only occur under fluoroscopy.
• The device should not be advanced into a vessel having a reference vessel
diameter smaller than the sheath outer diameter.
• The device should not be forced through an area of resistance unless the
source of resistance is identified by fluoroscopy and appropriate steps are
taken to reduce or remove the obstruction.
• Due to its tapered design, the outer sheath of this set can only
accommodate an inner device with an outer diameter of 4.0 French or
smaller.
POTENTIAL ADVERSE EVENTS
Vascular catheterization and/or vascular interventions may result in
complications including, but not limited to:
• Vessel dissection
• Perforation
• Total occlusion
• Embolism
• Vessel spasm
• Death
INSTRUCTIONS FOR USE
1. Flush the Flexor sheath through its side arm with heparinized saline
solution or sterile water.
2. Flush the CXI Support Catheter with heparinized saline solution or sterile
water.
3. Wet the entire surface of both the sheath and the support catheter
with heparinized saline solution or sterile water. This will activate the
hydrophilic coating, making the surface of both devices lubricious.
4. Preassemble the set as follows:
a. Insert the Peel-Away sheath into the Flexor sheath's Check-Flo valve.
b. Gently advance the CXI Support Catheter through the Peel-Away
sheath into the Flexor sheath. CAUTION: Advancing the support
catheter into a sheath without a wire guide can easily cause kinking of
the catheter. Use extra caution during this process.
c. When the CXI Support Catheter is advanced completely into the Flexor
sheath, peel away and discard the Peel-Away sheath.
5. Under fluoroscopic guidance, introduce the preassembled device into the
vascular system over a previously placed wire guide.
6. Under fluoroscopic guidance, carefully advance the device to the desired
vascular location. Final positioning is accomplished by stepwise, short
advances of the wire guide, CXI Support Catheter, and Flexor sheath.
CAUTION: Be sure the wire guide tip is extended beyond the CXI Support
Catheter tip at all times, and the CXI Support Catheter tip is extended beyond
the Flexor sheath tip at all times.
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