BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE FLOPPY GUIDEWIRE 0.14 X 182 CM

    MDR report key: 3713083 · Received March 26, 2014

    Report

    Report Number
    MW5035338
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PCI OF THE MID RCA, IT WAS NOTED ON X-RAY THAT THE DISTAL TIP OF BOSTON SCIENTIFIC CHOICE 0.14 X 182 CM GUIDEWIRE (REF 12132-01, LOT #16603364) HAD BROKEN OFF INSIDE THE PT. TIP WAS TRAPPED WITH ANGIOPLASTY BALLOON AND REMOVED FROM THE PT. INFO SHARED WITH BOSTON SCIENTIFIC REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176418 CHOICE FLOPPY GUIDEWIRE 0.14 X 182 CM NONE MCW BOSTON SCIENTIFIC 16603364

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR