BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 1762881 · Received June 30, 2010

    Report

    Report Number
    1318694-2010-00007
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS USED FOR STENT IMPLANTATION WHICH IS AN OFF-LABEL USE. THE CATHETER IS INDICATED FOR PTA/PTV USE ONLY. THERE IS A WARNING STATEMENT IN THE IFU SAYING THAT THESE ARE NOT TO BE USED FOR STENT REDILATATION.

    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-6575

    Patients

    Seq Age Sex Outcome Treatment
    1