BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 4205784 · Received October 6, 2014

    Report

    Report Number
    4205784
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    June 9, 2014
    Report Date
    October 2, 2014
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TYSHAK II BALLOON 8 X 3 WOULD NOT DEFLATE PROPERLY AFTER AORTIC VALVE VALVULOPLASTY, RESULTING IN ATTENDING HAVING TO INFLATE BALLOON FULLY UNTIL BURST CAUSING PSEUDOANEURYSM IN AORTA.PER MD: THE BALLON FAILED TO DEFLATE AND COULD NOT BE REMOVED FROM THE PATIENT UNTIL WE RUPTURED IT. THE PATIENT WAS EXPERIENCING POTENTIALLY DANGEROUS HYPERTENSION DUE TO AORTIC OBSTRUCTION BY THE BALLOON, SO URGENT REMOVAL OF THE BALLOON WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625023 TYSHAK II CATHETER, PERCUTANEOUS DQY NUMED, INC. TYSHAK II 8 X 3 TT-9442

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO