BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING BALLOON ULTRA 2

    MDR report key: 485488 · Received August 22, 2003

    Report

    Report Number
    485488
    Event Type
    Injury
    Date Received
    August 22, 2003
    Date of Event
    August 20, 2003
    Report Date
    August 21, 2003
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUTTING BALLOON INSERTED INTO SFR(R) FILLED AND THEN WOULD NOT DEFLATE. MULTIPLE TECHNIQUES USED TO DEFLATE: MANUAL, CUT OFF END, PROTECTION DEVICE, LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON ULTRA 2 CUTTING BALLOON LOX BOSTON SCIENTIFIC CUTTING BALLOON ULTRA2 4.00 X 15MM FT0311313

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization