ONE SNARE®
Received May 21, 2024 · Event occurred May 9, 2024
Report 9616662-2024-00019 · MDR key 19360403
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical Ireland LtdCatalog number
ONE400/B
Lot number
K2595116
Product problems
- Fracture
- Material Separation
- Fracture
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE LOOP OF THE ONE SNARE DEVICE DETACHED DURING THE RETRIEVAL OF ANOTHER DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE COULD NOT BE ESTABLISHED; HOWEVER, IT IS MOST LIKELY ATTRIBUTED TO CLINICAL USE AND EXCESSIVE FORCE DURING USE. 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.