EN SNARE®.
Received Sep 8, 2022 · Event occurred Aug 26, 2022
Report 9616662-2022-00017 · MDR key 15380222
Device
Generic name
Percutaneous Retrieval Device
Manufacturer
Merit Medical SystemsCatalog number
EN2007030/B
Lot number
K2387461
Product problems
- Fracture
- Material Separation
- Fracture
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS EXAMINED VISUALLY AND MICROSCOPICALLY. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER, IT IS LIKELY THAT SIGNIFICANT FORCE WAS APPLIED TO THE DEVICE DURING CLINICAL USE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.
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 URETERIC STENT REMOVAL PROCEDURE, THE DISTAL PORTION OF A VASCULAR SNARE DEVICE DETACHED WITHIN THE PATIENT DURING THE REMOVAL PROCESSES. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH ANOTHER VASCULAR SNARE DEVICE LIBERATING THE VESSEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED FOR THIS PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.