ATRIEVE VASCULAR SNARE KIT 3.2FR
Received May 16, 2022 · Event occurred Apr 26, 2022
Report 0001625425-2022-01005 · MDR key 14407007
Device
Generic name
Atrieve Vascular Snare Kit
Manufacturer
Argon Medical DevicesModel number
381003008Catalog number
381003008
Lot number
11198100
Product problems
- Break
- Entrapment of Device
- Migration or Expulsion of Device
Patient
Unknown
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.
Description of Event or Problem
CELT DEVICE DID NOT DEPLOY FULLY. CLIP BROKE AND FREE FLOATED DOWN THE RIGHT LEG. SNARE USED FOR RETRIEVAL, WIRE BROKE DURING ATTEMPTED REMOVAL FROM THE LEFT FEMORAL ACCESS. SNARE AND CLIP REMAIN IN THE PLACE IN THE LEFT
Description of Event or Problem
CELT DEVICE DID NOT DEPLOY FULLY. CLIP BROKE AND FREE FLOATED DOWN THE RIGHT LEG. SNARE USED FOR RETRIEVAL, WIRE BROKE DURING ATTEMPTED REMOVAL FROM THE LEFT FEMORAL ACCESS. SNARE AND CLIP REMAIN IN THE PLACE IN THE LEFT.
Additional Manufacturer Narrative
A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. AFTER THREE NOTIFICATIONS, THE SAMPLE FROM THE ALLEGED COMPLAINT HAS NOT BEEN RETURNED FROM THE CUSTOMER TO ARGON. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, DETERMINING ROOT CAUSE OR CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, THIS COMPLAINT MAY BE REOPENED FOR FURTHER EVALUATION AT THAT TIME.