InjurySCZ

PI-CARDIA SHORTCUT TRANSCATHETER LEAFLET SPLITTING DEVICE

Received Nov 24, 2025

Report MW5179338 · MDR key 23631368

Device

Generic name

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant

Manufacturer

Pi-cardia Ltd.

Model number

CATHETER 16 FR 115CM

Catalog number

Z-A-20.003-US

Lot number

SCUS-00006

Product problems

Break
Unraveled Material

Patient

81 YR · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

PI-CARDIA SHORTCUT TRANSCATHETER LEAFLET SPLITTING DEVICE BROKE THE WIRE IT WAS ADVANCED ON AND RENDERED IT UNUSABLE. THE WIRE UNRAVELED WITHIN THE DEVICE REQUIRING REMOVAL OF THE DEVICE AND SUCCESSFUL USE OF A NEW SECOND DEVICE.