BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYSHAK II

    MDR report key: 12894448 · Received November 30, 2021

    Report

    Report Number
    1318694-2021-00012
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    October 22, 2021
    Report Date
    November 30, 2021
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS RECEIVED FROM NUMED'S FOREIGN DISTRIBUTOR IN (B)(6). IT WAS SENT TO THEM FROM TGA, AS IT WAS REPORTED TO THE REGULATORY BODY. THE REPORTER IS MARKED AS CONFIDENTIAL SO THE DISTRIBUTOR IS UNABLE TO FOLLOW UP WITH THE FACILITY TO OBTAIN MORE INFORMATION. THERE IS VERY LITTLE INFORMATION GIVEN WITHIN THE REPORT FROM THE TGA. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE FOUND. ALL DEVICES WITHIN THE LOT MET ALL REQUIREMENTS FOR RELEASE AND DISTRIBUTION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. A REVIEW OF THE BALLOON MATERIAL USED SHOWS THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE BALLOON MATERIAL USED TO MANUFACTURE THE BALLOONS USED ON THIS LOT OF CATHETERS. IT WAS NOTED IN THE TGA REPORT THAT THIS DEVICE WAS BEING USED FOR AORTIC VALVULOPLASTY WHICH IS AN OFF-LABEL USE. THIS DEVICE IS ONLY APPROVED FOR USE IN PULMONARY VALVULOPLASTY. IT IS UNKNOWN AS TO WHAT PRESSURE THIS BALLOON CATHETER WAS TAKEN TO AND WHAT PRESSURE THE BALLOON BURST AT. A COMPARATIVE CATHETER WAS TESTED. THIS CATHETER WAS THE SAME CATALOG NUMBER, BUT A DIFFERENT LOT NUMBER. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED UNTIL IT FAILED. THE COMPARATIVE CATHETER DID NOT BURST UNTIL 3.5 ATM, WHICH IS MORE THAN THE LABELED RATED BURST PRESSURE OF 2 ATM.

    Description of Event or Problem · 0

    AS PER THE REPORT SENT TO NUMED FROM THEIR FOREIGN DISTRIBUTOR WHO RECEIVED IT FROM TGA - FOLLOWING SECOND INFLATION FOR AORTIC VALVULOPLASTY, BALLOON BURST AND BROKE INTO 2 PIECES INSIDE THE PATIENT, WHICH NEEDED TO BE RETRIEVED INDIVIDUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795129 TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER LIT NUMED, INC. 105 TT-16832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention