BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1662656 · Received April 14, 2010

    Report

    Report Number
    MW5015574
    Event Type
    Injury
    Date Received
    April 14, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 14, 2010
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ERCP, THE SURGEON ATTEMPTED TO BACKFEED A .035 HYDRAJAG INTO A 10 X 60 MM WALLSTENT AND WIRE SHED OUTER COVERING MAKING IT IMPOSSIBLE FOR THE NURSE TO USE THAT WALLSTENT. A SECOND 10 X 60 MM WALLSTENT PULLED AND TRIED TO FEED INTO ALREADY IMPLANTED WALLSTENT SNAGGED ON WALLSTENT AND WAS UNABLE TO ADVANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC WALLSTENTS NIO 7064 13294057

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Disability