MalfunctionMCW
VIPERWIRE ADVANCED WITH FLEX TIP
Received Jul 16, 2026 · Event occurred Jul 8, 2026
Report MW5190805 · MDR key 25842665
Device
Generic name
Catheter, Peripheral, Atherectomy
Lot number
592016-1
Patient
86 YR · Male
- Foreign Body In Patient
Narrative
Description of Event or Problem
PATIENT IN CATH LAB FOR LOWER EXTREMITY ANGIOGRAM AND INTERVENTION. LEFT POSTERIOR TIBIAL ARTERY WIRED WITH .014 X 300 COMMAND WIRE AND .018 CXI MICROCATHETER. COMMAND WIRE EXCHANGED WITH .014 X 335 CM VIPERWIRE FOR ATHERECTOMY. ATHERECTOMY PERFORMED BY 1.25 X 145 CM CSI MICRO DIAMONDBACK CATHETER. CSI MICROCATHETER REMOVED SUCCESSFULLY HOWEVER, VIPERWIRE BROKE OFF IN PATIENT'S BODY (LEFT FOOT). ATTEMPTS TO SNARE WIRE FRAGMENT MADE WITH 4 MM MICROSNARE (UNSUCCESSFUL). SUCCESSFULLY SNARED WITH 4-8 MM ENSNARE.