BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK MINI

    MDR report key: 6976383 · Received October 25, 2017

    Report

    Report Number
    1318694-2017-00027
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    July 10, 2017
    Report Date
    October 25, 2017
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    UDI-DI
    04046964339714
    PMA / PMN Number
    K003276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS NOT RETURNED TO NUMED FOR INVESTIGATION. THE ORIGINAL USER FACILITY MEDWATCH REPORT PROVIDED ONLY MINIMAL INFORMATION. THE USER FACILITY WAS CONTACTED AND WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. SINCE THE LOT NUMBER IS NOT KNOWN, THE MANUFACTURE DATE AND EXPIRATION DATE CAN'T BE CONFIRMED. THIS DEVICE WAS NOT USED ON A PATIENT. A SAMPLE CATHETER OF THE SAME CATALOG NUMBER WAS PULLED AND TESTED FOR INFLATION/DEFLATION SPECIFICATIONS. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED TO RATED BURST PRESSURE OF 4 ATM. A VACUUM WAS THEN DRAWN ON THE CATHETER. THE TIME UNTIL TOTAL DEFLATION WAS MEASURED. THE CATHETER REACHED FULL DEFLATION IN 7 SECONDS, WHICH IS WELL BELOW THE 10 SECONDS SPECIFICATION FOR DEFLATION TIME FOR THIS CATALOG NUMBER.

    Description of Event or Problem · 1

    AS PER THE MEDWATCH REPORT RECEIVED FROM THE FDA - "WHILE PREPPING THE BALLOON, THE BALLOON WOULD NOT DEFLATE COMPLETELY. A NEW BALLOON WAS OBTAINED AND PROCEDURE WAS COMPLETED. ORIGINAL DEVICE WAS NOT USED ON PATIENT. REPORTEDLY, THERE WAS NO HARM TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755431 TYSHAK MINI PEDIATRIC PULMONARY VALVULOPLASTY CATHETER DQY NUMED, INC. 107 04046964339714

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA