Device product
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Z-0774-2021
Product summary
- Event
- Event 86909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-0774-2021
Official wording
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Code information: Lot Number: 26152465, 26152466, 26152467 Exp. Date: 10/8/2022 GTIN: 08714729904595
Distribution pattern: US Nationwide distribution - Foreign: TBD.
Derived failure modes
-
Unknown
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity