EN SNARE
Received Feb 23, 2022 · Event occurred Feb 14, 2022
Report 9616662-2022-00005 · MDR key 13588588
Device
Generic name
Percutaneous Vascular Snare
Manufacturer
Merit Medical SystemsCatalog number
EN2007030/B
Lot number
K2254244
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 AN INFERIOR VENA CAVA FILTER REMOVAL PROCEDURE ON A REFERRAL PATIENT, THE TIP OF A VASCULAR SNARE DEVICE DETACHED WITHIN THE PATIENTS IVC. A SECOND VASCULAR SNARE DEVICE WAS PREPPED AND DEPLOYED IN ATTEMPTS TO REMOVE THE PRIMARY FOREIGN BODY FROM THE PATIENT WHEN THE TIP OF THE SECOND SNARE DEVICE ALSO DETACHED. THE PHYSICIAN STATES THAT USUAL RESISTANCE WAS EXPERIENCED DURING THE REMOVAL PROCEDURE EVEN THOUGH THE FILTER WAS EMBEDDED WITHIN THE WALL OF THE IVC. ORIGINAL IMPLANT DATE IN UNKNOWN. NO ADDITIONAL 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 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 ONE SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.