Device Description; Intended Use - COOK Medical Evolution Shortie RL Instructions For Use Manual

ENGLISH
Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set
Federal law restricts this device to sale by or on the order of a physician.

DEVICE DESCRIPTION

The Evolution® Shortie 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

Evolution® Shortie 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
Use With Other Devices
The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set may be used in conjunction with the
following catheter/lead extraction devices from Cook:
Locking Stylet
Lead Extender
Be sure to closely follow the "Suggested Instructions for Use" for each device used.
CONTRAINDICATIONS
None known
WARNINGS
Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set should only be used to minimally
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enter the vessel.
Do not attempt to negotiate the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set
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past a bend in the vessel as vessel wall or cardiac lead insulation damage may occur.
When using dilator sheaths or sheath sets, do not insert more than one sheath set into a vein at a
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time. Severe vessel damage, including venous wall laceration requiring surgical repair, may occur.
When using a Locking Stylet:
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Do not abandon a catheter/lead in a patient with a Locking Stylet still in place inside the
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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,
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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
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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
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when:
The item to be removed is of a dangerous shape or configuration,
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The likelihood of catheter/lead disintegration resulting in fragment embolism is high or
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vegetations are attached directly to the catheter/lead body.
Catheter/lead removal devices should be used only at institutions with thoracic surgical
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capabilities.
Catheter/lead removal devices should be used only by physicians knowledgeable in the
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techniques and devices for catheter/lead removal.
PRECAUTIONS
• When activating the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set be careful not to cut
or ensnarl lead suture-ties that are attached to the locking stylet targeted lead or to companion leads.
• Position the distal tip of the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set so that it does
not engage companion leads during activation.
• Prior to the procedure, consider the size of the catheter/lead in relation to the size of the LEAD
EXTRACTION™ devices to determine possible incompatibility.
• If selectively removing catheters/leads with the intent to leave one or more chronic catheters/leads
implanted intact, the non-targeted catheters/leads must be subsequently tested to ensure that they were
not damaged or dislodged during the extraction procedure.
Sheath Set
LR-EVN-SH-9.0-RL
LR-EVN-SH-11.0-RL
2