CARDIVA VASCADE MVP Manuel D'utilisation page 3

WARNINGS
• Do not use VASCADE if access is through a previously placed permanent closure device such as a metal clip and/or permanent
suture. Interference between the two closure devices may result.
• Do not deploy a second Collagen Patch at the same access site within 30 days. The previously implanted Collagen Patch may be
inadvertently introduced into the femoral vessel.
• Do not deploy the VASCADE Disc in a stent. Do not pull the deployed VASCADE Disc through a stent. Damage to the product
may occur.
• Do not reuse or re-sterilise. VASCADE is intended to be used once only for a single patient. Product reuse or re-sterilisation may
result in transmission of infectious or blood-borne diseases and/or death.
• Do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously
opened. Damaged or opened packages may compromise product functionality.
• Do not use if product is beyond the expiration date. Product performance has not been established beyond the shelf life on
the label.
• 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.
• DO NOT RELEASE the Collagen Patch if any part of the White Marker Stripe is showing (e.g. tissue tract is too short), as this may
increase the risk of infection if the collagen protrudes from the skin.
• Do not deploy the extravascular Collagen Patch if there is a suspicion that the Disc is not seated against the intimal aspect of the
vessel puncture site to avoid releasing the patch in the vessel. Partial or complete obstruction of blood flow may result. This step
requires image guidance.
• Grip the Lock to retract Black Sleeve. Do not grip the device distal to the Lock as this may result in operator injury which could
lead to possible infection.
PRECAUTIONS
• VASCADE should only be used by a trained, licensed physician or healthcare professional.
o Note: The training referred to here is previous training in vascular access and catheter placement and use. VASCADE does
not require formal training beyond reading the Instructions for Use.
• Do not use in vessels with suspected intraluminal thrombus, haematoma, pseudoaneurysm or arteriovenous (AV) fistula. These
conditions may interfere with the proper use and performance of the device.
• Do not use at the following access sites as the bleeding risk may increase:
o Access site with suspected back wall stick.
o Access site noted to be side stick.
o Access site is "high" above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric artery
origin from the external iliac artery inferior epigastric vein entry into the external iliac vein).
• During access, be careful that the tissue tract is not pushed laterally or medially before accessing the vessel. This is to avoid
misalignment of the tissue tract and the Collagen Patch relative to the vessel puncture site once the device is removed from the
vessel, which may prolong time to haemostasis.
• If more than one access is made in the vessel, keep a minimum of 6 mm separation between the access sites. This is to allow the
disc to track back to the vessel wall. Temporary haemostasis may not be achieved if the venotomies are too close to each other.
• 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.
• Do not use in a procedural sheath > 12 cm in length (or > 15 cm in overall length) or with a diameter other than 6–12F. This may
complicate Disc deployment.
• Do not advance VASCADE into the patient if resistance is felt due to risk of vascular injury.
• Do not soak the VASCADE Catheter in saline. This may result in Catheter pull-through during the sleeve retraction
step.Momentarily insert only the Catheter tip in saline solution immediately before use to avoid over-hydration of the patch.
• Do NOT continue to pull on the Black Actuator once it is locked in place, as this may damage the device.
• Compressing the access site during removal of the sheath may hinder the Disc from tracking back to the vessel puncture site and
cause Disc deformation. This may hinder achieving temporary haemostasis.
• Applying too much upward tension on the Black Actuator may cause Disc to pull out of vessel. Should this occur, convert to
Institution's Manual Compression Protocol.
• Not achieving temporary haemostasis may be an indication that the Disc is not against the vessel wall. Releasing the Collagen
Patch may result in all or a portion of the Patch to be deployed in the vessel.
IFU 5686 AE, 2024-04
Safety Messages
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