BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING BALLOON ULTRA

    MDR report key: 1081385 · Received July 7, 2008

    Report

    Report Number
    1081385
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUTTING BALLOON RUPTURED AT LOW PRESSURE 6 ATM. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON ULTRA CATHETER, DILATION, CUTTING LIT BOSTON SCIENTIFIC * EJ0100

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR