BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 4914924 · Received July 13, 2015

    Report

    Report Number
    1318694-2015-00004
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 13, 2015
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS RETURNED AND THE BALLOON BURST WAS CONFIRMED. A SAMPLE DEVICE WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THE LABELED RBP FOR THIS SIZE CATHETER IS 2.0 ATM. THE SAMPLE CATHETER WAS TESTED AND DID NOT RUPTURE UNTIL 3.5 ATM, WHICH IS WELL ABOVE THE LABELED RBP. THE FACILITY STATED THAT IT BURST BELOW NOMINAL PRESSURE, WHICH IS 1.5 ATM, HOWEVER, IT IS UNKNOWN AS TO WHAT PRESSURE THE PHYSICIAN TOOK THE CATHETER TO. THIS DEVICE WAS BEING USED OFF LABEL TO AORTIC VALVULOPLASTY. THIS CATHETER IS ONLY INDICATED FOR PULMONARY VALVULOPLASTY.

    Description of Event or Problem · 1

    AS REPORTED TO NUMED - "BALLOON RUPTURED BELOW NOMINAL PRESSURE WHILE BEING INFLATED ACROSS THE AORTIC VALVE. PROCEDURE THE BALLOON WAS BEING USED FOR IS AORTIC VALVULOPLASTY. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE SHAFT WAS NOT KINKED. THE BALLOON RUPTURED CIRCUMFERENTIALLY. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY. THE PATIENT WAS FINE POST PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453086 TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER DQY NUMED, INC. 105 TT-10513

    Patients

    Seq Age Sex Outcome Treatment
    1