Device Description; Intended Use; Contraindications - COOK Medical Evolution RL Gebrauchsanweisung

ENGLISH
Cook Vascular Incorporated
Evolution® RL Controlled-Rotation Dilator Sheath Set
Instructions for Use

DEVICE DESCRIPTION

The Evolution RL Controlled-Rotation Dilator Sheath Set is comprised
of an inner polymer sheath connected to a handle capable of
mechanically rotating the sheath and an outer telescoping polymer
sheath. The inner sheath has a stainless steel tip at its distal end.

INTENDED USE

The Evolution RL Controlled-Rotation Dilator Sheath Set is intended
for use in patients requiring the percutaneous dilation of tissue
surrounding cardiac leads, indwelling catheters and foreign objects.
Sheath Size
9 Fr
11 Fr
13 Fr
Use With Other Devices
The Evolution RL Controlled-Rotation Dilator Sheath Set may be
used in conjunction with the following catheter/lead extraction
devices from COOK Vascular Incorporated:
Locking Stylet
Lead Extender
Be sure to closely follow the "Suggested Instructions for Use" for
each device used.

CONTRAINDICATIONS

None known
WARNINGS
• When using sheaths, do not insert sheaths over more than
one lead at a time. Severe vessel damage, including venous wall
laceration requiring surgical repair, may occur.
• When using a Locking Stylet:
• Do not abandon a catheter/lead in a patient with a Locking
Stylet still in place inside the catheter/lead. Severe vessel
or endocardial wall damage may result from the stiffened
catheter/lead or from fracture or migration of the abandoned
stylet wire.
• Do not apply weighted traction to an inserted Locking Stylet
as myocardial avulsion, hypotension, or venous wall tearing
may result.
• Be aware that a lead that has a J-shape retention wire that
occupies its inner lumen (rather than being outside the coil)
may not be compatible with the Locking Stylet. Insertion of the
Locking Stylet into such a lead may result in protrusion and
possible migration of the J-shape retention wire.
• Weigh the relative risks and benefits of intravascular catheter/
lead removal procedures in cases when:
• The item to be removed is of a dangerous shape or
configuration,
• The likelihood of catheter/lead disintegration resulting in
fragment embolism is high or vegetations are attached directly
to the catheter/lead body.
• Catheter/lead removal devices should be used only at
institutions with thoracic surgical capabilities.
• Catheter/lead removal devices should be used only by
physicians knowledgeable in the techniques and devices for
catheter/lead removal.
Federal law restricts this device to sale by or on the order
of a physician.
LR-EVN-9.0-RL
LR-EVN-11.0-RL
LR-EVN-13.0-RL
Sheath Set
2