InjurySCZ
PI-CARDIA SHORTCUT TRANSCATHETER LEAFLET SPLITTING DEVICE
Received Jul 18, 2025 · Event occurred Jul 8, 2025
Report MW5172928 · MDR key 22543917
Device
Generic name
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant
Manufacturer
Pi-cardia IncModel number
CATHETER 16 FR 115 CMCatalog number
Z-A-20.003-US
Lot number
SCUS-00005
Product problems
- Entrapment of Device
Patient
77 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PI-CARDIA SHORTCUT TRANSCATHETER LEAFLET SPLITTING DEVICE GOT STUCK ON THE WIRE OF THE DEVICE WHILE IN THE PATIENT'S BODY. THE DEVICE AND WIRE WERE REMOVED FROM THE PATIENT. A NEW SECOND DEVICE WAS THEN USED TO SUCCESSFULLY REWIRE THE LEFT VENTRICLE.