BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIELDER XT (ASAHI WIRE) DISTRIBUTED BY ABBOTT VASCULAR

    MDR report key: 2142466 · Received June 22, 2011

    Report

    Report Number
    MW5021127
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ASAHI/ABBOTT MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CTO PER DR. (B)(6) "A FIELDER XT WAS BROUGHT, AS WAS ANOTHER 15 MM OF SEGMENT OUTSIDE THE STENT, TO THE DISTAL CAP AND, BECAUSE OF THE ANATOMIC AMBIGUITY, WANTED TO USE A SUBINTIMAL TECHNIQUE. HOWEVER, WE COULD NOT GET THE XT TO EXIT THE STENT. AS WE TRIED TO KNUCKLE IT, IT ENTWINED. AS WE TRIED TO REMOVE IT, IT WAS EMBEDDED IN THE STENT TISSUE, AND THE TIP WAS FRACTURED OFF. THE CORSAIR HAD TO BE REMOVED AT THE SAME TIME TO REMOVE THE BODY OF THE GUIDE WIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIELDER XT (ASAHI WIRE) DISTRIBUTED BY ABBOTT VASCULAR PTCA GUIDEWIRE DQX ASAHI/ABBOTT MEDICAL AGP140002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR