BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 2043357 · Received February 25, 2011

    Report

    Report Number
    1318694-2011-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    November 2, 2010
    Report Date
    February 25, 2011
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K030589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS NOT RETURNED TO NUMED FOR EVAL. A CATHETER FROM INVENTORY WAS PULLED AND TESTED. IT BURST ABOVE THE RATED BURST PRESSURE ON THE LABELING. IT IS UNK AS TO WHAT PRESSURE THIS CATHETER WAS TAKEN TO. TYPICALLY, BALLOON BURSTS ARE CAUSED BY OVER INFLATION OR CALCIFIED AREAS.

    Description of Event or Problem · 1

    BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II CATHETER PTV CATHETER DQY NUMED, INC. 105 TT-6620

    Patients

    Seq Age Sex Outcome Treatment
    1