EN SNARE®.
Received Dec 13, 2022 · Event occurred Dec 7, 2022
Report 9616662-2022-00023 · MDR key 15974091
Device
Generic name
Percutaneous Retrieval Device
Manufacturer
Merit Medical SystemsModel number
00884450452462Catalog number
EN2006020/B
Lot number
K2520311
Product problems
- Fracture
- Material Separation
- Fracture
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE HEAD OF THE VASCULAR SNARE DEVICE DETACHED WITHIN THE PATIENT. THE PATIENT REQUIRED SURGICAL INTERVENTION TO RETRIEVE THE FOREIGN BODY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY AND MICROSCOPICALLY. FUNCTIONAL TESTING WAS PERFORMED. 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.