Potential Adverse Events - COOK Medical Evolution RL Instructions For Use Manual

Controlled-rotation dilator sheath set

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As a result of the risk of complications, doctors highly experienced in this procedure have advised the

following:

PREPARATIONS

•

Obtain a thorough patient history, including patient blood type. Appropriate blood products should

be rapidly available.

•

Ascertain the manufacturer, model number, and implant date of the catheter/lead to be removed.

•

Perform radiographic/echocardiographic evaluation of catheter/lead condition, type, and position.

Use a procedure room that has high quality fluoroscopy, pacing equipment, defibrillator, thoracotomy

tray, and pericardiocentesis tray.

•

Echocardiography and cardiothoracic surgery should be rapidly available.

•

Prep/drape the patient's chest for possible thoracotomy; prep/drape the patient's groin for femoral

approach or possible femoral approach.

•

Establish back up pacing as necessary.

•

Have available an extensive collection of sheaths, Lead Control Devices (Locking Stylet and Lead

Extender), stylets to unscrew active fixation leads, snares, and accessory equipment.

PROCEDURE

•

Use fluoroscopic monitoring during ALL catheter/lead and sheath manipulations. Monitor ECG and

arterial blood pressure continuously throughout the procedure and during recovery.

•

If using sheaths or sheath sets, including the Evolution or Evolution RL Controlled-Rotation Dilator

Sheath Set, the following precautions should be followed:

•

Prior to using sheaths including the Evolution or Evolution RL Controlled-Rotation Dilator Sheath

Set it is essential to carefully inspect the extravascular catheter/lead tract to ensure removal of all suture

sleeves, sutures, and tie-down materials.

•

The Evolution Shortie RL Controlled-Rotation Dilator Sheath Set or Byrd Telescoping Stainless Steel

Dilator Sheath Set should be used only to minimally enter the vessel.

•

Be aware that insertion of a stainless steel dilator sheath over a Byrd Dilator Sheath Set

Polypropylene, the Evolution or Evolution RL Controlled-Rotation Dilator Sheath Set may damage the

inner sheath.

•

When advancing sheaths including the Evolution or Evolution RL Controlled-Rotation Dilator Sheath

Set, use proper sheath technique and maintain adequate tension on the catheter/lead (via a Locking

Stylet or directly) to avoid damage to vessel walls.

•

If excessive scar tissue or calcification prevents safe advancement of sheaths, consider an alternate

approach.

•

Excessive force with sheaths, including the Evolution or Evolution RL Controlled-Rotation Dilator

Sheath Set used intravascularly may result in damage to the vascular system requiring surgical repair.

•

If the catheter/lead breaks, evaluate fragment; retrieve as indicated.

•

If hypotension develops, rapidly evaluate; treat as appropriate.

•

Due to rapidly evolving catheter/lead technology, this device may not be suitable for the removal of

all types of catheters/leads. If there are questions or concerns regarding compatibility of this device with

particular catheters/leads, contact the catheter/lead manufacturer.