BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDIT ANGIOPLASTY BALLOON, 2.5MM

    MDR report key: 25309 · Received September 8, 1995

    Report

    Report Number
    MW1006877
    Event Type
    Malfunction
    Date Received
    September 8, 1995
    Date of Event
    August 30, 1995
    Report Date
    August 31, 1995
    Manufacturer
    SCIMED LIF SYSTEMS
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WITH INITIAL INFLATION OF THE BALLOON TO 6 ATMS, ONLY THE DISTAL HALF INFLATED. AFTER DEFLATION & RE-INFLATION TO 12 ATMS, THE DISTAL HALF OF THE BALLOON INFLATED FOLLOWED SOME 5-10 SECONDS LATER BY THE PROXIMAL HALF. WITH ATTEMPTED DEFLATION, THE DISTAL HALF OF THE BALLOON DEFLATED BUT THE PROXIMAL HALF REMAINED INFLATED. EXTRA SUCTION WAS APPLIED BY DISCONNECTING THE INFLATION DEVICE WHILE MAINTAINING NEGATIVE PRESSURE ON THE BALLOON & THEN REAPPLYING SUCTION WITH THE INFLATION DEVICE. THIS RESULTED IN SLOW PARTIAL DEFLATION OF THE PROXIMAL HALF OF THE BALLOON WHICH WAS THEN SUCCESSFULLY WITHDRAWN & REMOVED FROM THE PT. AFTER EXCHANGING BALLOONS, THE PROCEDURE WAS SUCCESSFUL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FROM THE PROBLEMS WITH THE INITIAL BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANDIT ANGIOPLASTY BALLOON, 2.5MM BALLOON LIT SCIMED LIF SYSTEMS B1420/25 456974

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR