MalfunctionMMX
PEEL AWAY SHEATH
Received May 9, 2025 · Event occurred Mar 26, 2025
Report 1721504-2025-00055 · MDR key 21999044
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical Systems Inc - MexicoCatalog number
FCL-174-00/B
Product problems
- Failure to Unfold or Unwrap
- Failure to Unfold or Unwrap
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INVESTIGATED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE IDENTIFIED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS IDENTIFIED.
Description of Event or Problem
THE PEEL AWAY SHEATH WAS DIFFICULT TO PEEL, TAKES A LOT OF FORCE TO PEEL.