CARDIVA VASCADE MVP Manuel D'utilisation page 13

PREPARATION STEPS: Patient Access Considerations and Device Preparation
Prep-A: Patient Access Considerations and Preparation for Closure
Access
1. Access is gained at the beginning of the index procedure for initial procedural sheath
placement. Image-guided access is recommended to limit potential access site issues,
such as multiple sticks, backwall stick, high stick, side stick, through-and-through or
unintentionally nicking a nearby vein or artery. During access, where more than one
hole is unintentionally made in a vessel or more than one vessel is perforated at a
single access site, a closure device should not be used as it may result in a
haematoma. For high stick, retroperitoneal bleeding may result.
2. Evaluate patient body build or use ultrasound to provide reasonable assurance that
the tissue tract is greater than 2.5 cm.
Prior to Closure
3. Confirm a single wall common femoral vessel puncture site.
4. Record an anterior oblique fluoroscopic image with contrast or an ultrasound image
(optional) so that the vessel puncture site location can be subsequently compared to
the position of the radiopaque marker (or echogenic disc) just before Collagen Patch
release. Reference Step 1 Part B for imaging steps during closure.
5. Verify sheath compatibility (e.g. length) and swap for a different sheath if necessary.
Reference Technical Specifications.
Multi-Site Access & Closure
6. The distance between the access sites should be kept at a minimum of 6 mm. Keep
the stick separation at the skin level at a minimum of 6 mm and drive the needles to
the vein at the same angle to keep the separation between adjacent venotomies at a
minimum of 6 mm. Imaging techniques such as ultrasound can be used to confirm the
separation is as recommended.
7. If more than one sheath is used in the same vein, it is recommended to close the
proximal venotomy first to facilitate device placement and imaging prior to Collagen
Patch release.
Prep-B: Unpack the Device
1. Inspect the package for damage (breaks, tears, open seals, water damage, etc.).
2. Check that the expiry date has not passed.
3. Check that the correct product and size is used.
4. Remove the tray from the foil pouch using standard sterile technique (see Aseptic
Presentation below).
5. Remove the Catheter and Clip from the tray.
Aseptic Presentation
1. Place near the sterile field. Check that the scrubbed person to whom the product
is passed is ready to receive it with a clear space in the field.
2. All sterile packages have a designated side to open from. Locate this side and
slowly peel the package open.
3. Open the package with arms extended to avoid accidental contact with the
product or sterile field. The secondary packaging is not considered sterile and
must not touch the edges of the primary packaging. Create a large enough
opening in the package to remove the primary packaging without touching the
non-sterile areas.
4. Present the product to the scrubbed person.
5. Discard packaging following facility protocol.
IFU 5686 AE, 2024-04
CAUTIONS
• 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.
WARNINGS
• 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.
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