CARDIVA VASCADE MVP Manuel D'utilisation page 15

Prep-D: Prepare the Sheath
1. Verify that the sheath is not positioned in a tortuous vessel (i.e. by examining
the sheath placement images obtained earlier).
2. If required, retract the sheath slightly to a non-tortuous location and verify the
sheath is still positioned within the vessel.
3. Flush the sheath with sterile saline solution.
Note: If more than one sheath is in the vein, retract the most proximal sheath (top
sheath) so that the distal opening of that sheath is proximal to the distal opening of
other sheaths by 3–4 cm. This is to eliminate interference of a deployed Disc with
other indwelling sheaths during device deployment. Care must be taken not to lose
vessel access. Deploy the device and obtain haemostasis in the most proximal
sheath first (as per steps outlined below). Then move distally to repeat the steps to
obtain closure for the other sheaths.
IFU 5686 AE, 2024-04
WARNING
Check for the absence of vessel tortuosity or side
branches within 3-4 cm from the distal opening of
the sheath and that the end of the sheath is not
resting against the vessel wall. This is to prevent
vascular injury during Catheter placement. If
necessary, retract the sheath slightly to a non-
tortuous location, making sure not to lose
vascular access.
CAUTION
Do not use if intra-procedural bleeding around
the introducer sheath is noted, including
haematoma formation (sign of possible multiple
wall stick). This may suggest problems with the
access site.
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