BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 4319667 · Received November 26, 2014

    Report

    Report Number
    1318694-2014-00004
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    June 9, 2014
    Report Date
    November 26, 2014
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS BEING USED OFF-LABEL FOR AORTIC VALVULOPLASTY. THE CLEARED INDICATION FOR THIS DEVICE IS FOR PULMONARY VALVULOPLASTY. THE MALFUNCTION OCCURRED IN (B)(6) OF 2014 BUT WAS NOT REPORTED TO THE FDA OR NUMED UNTIL OCTOBER OF 2014. THE DEVICE WAS NOT RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED, AND EVALUATION OF THE DEVICE IS PERFORMED, ADDITIONAL INFO WILL BE SENT TO THE FDA IN A F.U REPORT.

    Description of Event or Problem · 1

    AS DESCRIBED IN THE USER FACILITY REPORT - (B)(4): 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 BALLOON 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
    769649 TYSHAK II PERCUTANEOUS CATHTER, DQY DQY NUMED, INC. 105 TT-9442

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO