BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALL FLEX COLONIC STENT

    MDR report key: 2243940 · Received September 6, 2011

    Report

    Report Number
    MW5022151
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MQR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A COLONIC STENT WAS PLACED WITHOUT COMPLICATIONS. UPON REVIEW OF PLACEMENT, PROTRUDING WIRE NOTED AT END OF STENT. POTENTIAL FOR BOWEL PERFORATION. PHYSICIAN AND BOSTON SCIENTIFIC REP IN COLLABORATION HEATED THE PROTRUDING WIRE AND SUCCESSFULLY CUT THE WIRE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALL FLEX COLONIC STENT STENT WITH ANCHOR LOCK DELIVERY MQR BOSTON SCIENTIFIC M00565040 14499356

    Patients

    Seq Age Sex Outcome Treatment
    1