BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2335018 · Received November 8, 2011

    Report

    Report Number
    MW5023048
    Event Type
    Other
    Date Received
    November 8, 2011
    Date of Event
    October 26, 2011
    Report Date
    October 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAVING FISTULOGRAM COMPLETED IN (B)(6). INITIAL CUTTING BALLOON WAS USED IN PROCEDURE THAT RUPTURED THAT WAS FULLY RECOVERED. A SECOND BALLOON WAS USED WITH THE SAME RESULT. A THIRD BALLOON WAS USED THAT RESULTED IN RESOLUTION OF THE STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CUTTING BALLOON 8/2 LIT BOSTON SCIENTIFIC 14244406
    2 BOSTON SCIENTIFIC CUTTING BALLOON 8/2 LIT BOSTON SCIENTIFIC 14415767

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR