BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 2493812 · Received March 12, 2012

    Report

    Report Number
    1318694-2012-00005
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    September 27, 2011
    Report Date
    March 12, 2012
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS REPORTED AS A BALLOON LEAK. AFTER INVESTIGATION AND REVIEW OF THE COMPLAINT CATHETER IT WAS DISCOVERED THAT THE BALLOON BURST CIRCUMFERENTIALLY. A COMPARATIVE CATHETER WAS PULLED FROM STOCK AND TESTED FOR RATED BURST PRESSURE. THE CATHETER BURST AT 3.5 ATM, WHICH IS ABOVE THE LABELED RBP OF 2.0 ATM. IT DOES NOT STATE IN THE REPORT IF AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED AS IS RECOMMENDED IN THE INSTRUCTIONS FOR USE. IT IS ALSO UNK AS TO WHETHER THIS DEVICE WAS USED MORE THAN ONCE OR WHAT PRESSURE THE BALLOON WAS TAKEN TO AND WHAT PRESSURE IT BURST AT.

    Description of Event or Problem · 1

    BALLOON STARTED LEAKING DURING FIRST INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II CATHETER PTV CATHETER LIT NUMED, INC. 105 TT-7380

    Patients

    Seq Age Sex Outcome Treatment
    1