BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAWIRE FLOPPY GUIDE WIRE

    MDR report key: 1811268 · Received August 13, 2010

    Report

    Report Number
    1811268
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    April 22, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE ARTERY WAS HIGHLY CALCIFIED AND 100% BLOCKED. THE BLOCKAGE WAS CROSSED WITH A WIRE BUT THE CATHETER WOULD NOT CROSS. A ROTAWIRE FLOPPY GUIDE WIRE WAS INSERTED AND ON THE THIRD PASS OF THE ROTABLATOR, THE WIRE SNAPPED AND THE PROXIMAL CIRCUMFLEX ARTERY WAS PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTAWIRE FLOPPY GUIDE WIRE GUIDE WIRE, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC * 12919143

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR