Potential Adverse Events - COOK Medical Evolution RL Gebrauchsanweisung

POTENTIAL ADVERSE EVENTS

Potential adverse events related to the procedure of intravascular
extraction of catheters/leads include (listed in order of increasing
potential effect):
dislodging or damaging nontargeted catheter/lead
chest wall hematoma
thrombosis
arrhythmias
acute bacteremia
acute hypotension
pneumothorax
stroke
migrating fragment from catheter/object
pulmonary embolism
laceration or tearing of vascular structures or the myocardium
hemopericardium
cardiac tamponade
hemothorax
death
INSTRUCTIONS FOR USE
Suggested Instructions for Use
Evolution RL Controlled-Rotation Dilator Sheath Set
WARNING: 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.
SUPERIOR APPROACH
1. Surgically expose the proximal end of the indwelling catheter/lead
and remove the catheter/lead from its connections (if connected).
Remove all suture and tie-down materials.
2. Cut off all proximal fittings, if present, using clippers or other cutters.
It is important to cut the catheter/lead very close to the connector
(but past any crimp joints) leaving as long a portion of the indwelling
catheter/lead to work with as possible. Avoid closing off the interior
lumen (or coil) of the catheter/lead when cutting it.
3. Consider passing a Locking Stylet through the inner lumen of
the catheter/lead to stabilize the catheter/lead during dilation of
surrounding tissues. Closely follow the "Suggested Instructions for Use"
for the Locking Stylet to:
A. Expose the inner coil of the catheter/lead
B. Check patency of the coil lumen
C. Determine the appropriate size of Locking Stylet based on the
inner diameter of the catheter/lead
D. Advance the Locking Stylet to the distal end of the catheter/lead
E. Lock the Locking Stylet in place
4. Unless the catheter/lead insulation is damaged, degraded or too thin,
tie a ligature at the proximal end of the catheter/lead, compressing
the insulation against the coil and Locking Stylet to help prevent the
coil and insulation from stretching. The ligature can be tied to the loop
handle or to the suture tie loop.
NOTE: If a Locking Stylet has not been used, be aware that
damage to the catheter/lead caused by pulling on it may prevent
subsequent passage of a Locking Stylet through the lumen and/or
make dilation of scar tissue more difficult.
5. For an active fixation catheter/lead, attempt to unscrew the catheter/
lead by rotating the catheter/lead and Locking Stylet counterclockwise
if appropriate.
6. Gently pull back on the catheter/lead to see if it is still engaged in
tissue. If the catheter/lead is sufficiently loose in the tissue, gently pull
on the Locking Stylet and catheter/lead to remove it.
NOTE: If removing a chronic pacing lead, be aware that if it is
freed spontaneously during the extraction procedure, the lead tip
may become trapped in the upper vasculature. Dilator sheaths,
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