Device Description; Intended Use - COOK SteadySheath Evolution Instrucciones De Uso

ENGLISH
SteadySheath® Evolution® Tissue Stabilization Sheath
Instructions for Use

DEVICE DESCRIPTION

The SteadySheath Evolution Tissue Stabilization Sheath is comprised of
a PTFE sheath with a stainless steel distal tip.

INTENDED USE

The SteadySheath Evolution Tissue Stabilization Sheath is intended
for use in patients requiring the percutaneous dilation of tissue
surrounding cardiac leads, indwelling catheters and foreign objects.
Sheath
Size (I.D.)
9 Fr
11 Fr
13 Fr
Use With Other Devices
The SteadySheath Evolution Tissue Stablization Sheath may be used
in conjunction with the following catheter/lead extraction devices
from Cook:
Locking Stylet
Lead Extender
Evolution Mechanical Dilator Sheath Set
Evolution RL Controlled-Rotation Dilator Sheath Set
Evolution Shortie Mechanical Dilator Sheath Set
Evolution Shortie RL Controlled-Rotation Dilator Sheath Set
Be sure to closely follow the "Suggested Instructions for Use" for
each device used.
CONTRAINDICATIONS
None known
WARNINGS
When using dilator sheaths or sheath sets do not insert more
•
than one sheath set into a vein 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.
Compatible with
Evolution or Evolution
RL Sheath Sets
LR-TSS-9.0
LR-TSS-11.0
LR-TSS-13.0
Compatible with Evolution
Shortie or Evolution Shortie
RL Sheath Sets
LR-TSS-SH-9.0
LR-TSS-SH-11.0
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