Device product
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Z-0716-2020
Product summary
- Event
- Event 84399
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0716-2020
Official wording
Reason: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
Code information: Lot Number: 16F19H0093
Distribution pattern: U.S. Nationwide, Canada
Derived failure modes
-
Unknown
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death