BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2631605 · Received June 21, 2012

    Report

    Report Number
    MW5025943
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 29, 2012
    Report Date
    June 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO USE CRE FIXED WIRE BALLOON TO DILATE PT'S ESOPHAGUS. BALLOON WOULD NOT FIT DOWN SCOPE CHANNEL. CHANNEL LUBRICATED WITH MINERAL OIL WHICH DID NOT HELP. SCOPE TRADED OUT FOR SECOND EGD SCOPE. BALLOON WOULD NOT FIT DOWN THE SCOPE. OPENED SECOND BALLOON AND IT WENT DOWN SCOPE CHANNEL AND DILATION WAS COMPLETED. OF NOTE: EXCESS AIR WAS REMOVED FROM FIRST CRE PRIOR TO ATTEMPTED INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CRE FIXED WIRE ESOPHAGEAL BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC 5838 15145705

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR