EN SNARE MINI
Received Oct 18, 2023 · Event occurred Oct 9, 2023
Report 9616662-2023-00020 · MDR key 17958413
Device
Generic name
Intravascular Snare
Manufacturer
Merit Medical Systems, Inc.Catalog number
EN1003004/B
Lot number
K2607056
Product problems
- Fracture
- Fracture
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
CUSTOMER ALLEGES THE TIP OF THE SNARE BROKE OFF AND THEY USED ANOTHER SNARE TO REMOVE THE TIP. NO PATIENT INJURY.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE MOST PROBABLE CAUSE OF THIS OCCURRENCE IS FORCES IMPOSED UPON THE DEVICE WHEN TORTUOUS ANATOMY WAS ENCOUNTERED IN CLINIC. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.