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WARNINGS
Do not use VASCADE if access is through a previously placed permanent closure device such as a metal clip
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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
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Patch may be inadvertently introduced into the femoral vessel.
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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.
CAUTIONS
VASCADE should only be used by a trained, licensed physician or healthcare professional.
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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.
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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.
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Do not use at the following access sites as the bleeding risk may increase:
o
Access site with suspected back wall stick.
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Access site noted to be side stick.
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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).
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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.
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VASCADE should be stored at room temperature (15° – 25°C), otherwise proper device performance may be
affected.
NOTES
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See Figure 1 for an image of the device.
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Use the device only as described in the Technical Specifications (see Page 2).
IFU 5686 AE, 2024-04
Instructions for Use
Device Preparation and Procedure
General Use Instructions
Page 12 of 24
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