BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 1734001 · Received June 7, 2010

    Report

    Report Number
    1318694-2010-00004
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    April 27, 2010
    Report Date
    June 7, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A CATHETER FROM THE SAME LOT WAS PULLED FROM INVENTORY AND BENCH TESTING WAS PERFORMED. THE CATHETER HAS A LABELED RATED BURST PRESSURE OF 2.0 ATM AND A LABELED NOMINAL PRESSURE OF 1.5 ATM. THE COMPARATIVE CATHETER FROM THE SAME LOT BURST AT 4.0 ATM DURING THE BENCH TESTING. IT IS UNK WHETHER OR NOT AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED AS RECOMMENDED IN THE INSTRUCTIONS FOR USE.

    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 LIT NUMED, INC. 105 TT-6666

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR