BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 1762913 · Received June 30, 2010

    Report

    Report Number
    1318694-2010-00006
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 3, 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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS NOT YET BEEN RETURNED TO NUMED FOR EVAL. IN THE REPORT TO NUMED IT STATED THAT AN INFLATION DEVICE WITH PRESSURE GAUGE WAS NOT USED FOR THIS PROCEDURE. IT STATES IN THE INSTRUCTIONS FOR USE THAT AN INFLATION DEVICE WITH PRESSURE GAUGE SHOULD BE USED SO THAT THE RATED BURST PRESSURE OF THE CATHETER IS NOT EXCEEDED.

    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-6620

    Patients

    Seq Age Sex Outcome Treatment
    1