EN SNARE®
Received Apr 25, 2023 · Event occurred Apr 13, 2023
Report 9616662-2023-00005 · MDR key 16811542
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical SystemModel number
00884450452424Catalog number
EN1003004/JPA
Lot number
K2202063
Product problems
- Fracture
- Material Integrity Problem
- Fracture
- Material Integrity Problem
Patient
1 YR · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
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.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT 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 BALLOON DILATION PROCEDURE WITHIN THE PULMONARY ARTERY THROUGH THE FEMORAL VEIN OF A 1-YEAR-OLD PATIENT, THE TIP OF THE GUIDEWIRE DETACHED WHILE THE WIRE WAS WITHDRAWN. A SNARE WAS USED TO REMOVED THE TIP OF THE WIRE, AFTER GRIPPING THE TIP, RESISTANCE WAS FELT AND PART OF THE SNARE WIRE DETACHED AND REMAINED WITHIN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH THE TIP OF THE WIRE AND FRAGMENT OF THE SNARE LEFT WITHIN THE PATIENT IN THE PERIPHERAL REGION OF THE LUNG. PHYSICIAN DOES NOT CONSIDER REMAINING FRAGMENTS TO BE LIFE-THREATENING.