EN SNARE®
Received Jan 27, 2022 · Event occurred Jan 18, 2022
Report 9616662-2022-00003 · MDR key 13370313
Device
Generic name
Percutaneous Retrieval Device
Manufacturer
Merit Medical SystemsCatalog number
EN2007030/CNB
Lot number
K2138948
Product problems
- Material Separation
- Material Separation
Patient
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 A VASCULAR PROCEDURE INVOLVING A SNARE DEVICE, WHEN RETRIEVING THE VASCULAR SNARE FROM WITHIN THE CATHETER, THEY ALSO RETRIEVED SOME TYPE OF TRANSPARENT FOREIGN MATERIAL AS WELL. IT IS CURRENTLY UNKNOWN IF ANY OF THE FOREIGN MATERIAL HAD BEEN INADVERTENTLY INTRODUCED INTO THE PATIENT DURING USE. THE MATERIAL IN QUESTION IS NOT RADIOPAQUE. THE PATIENT WAS CLOSELY OBSERVED AND DISCHARGED AS EXPECTED WITH NO ADDITIONAL CONSEQUENCES TO REPORT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. 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.