BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK

    MDR report key: 3820171 · Received April 10, 2014

    Report

    Report Number
    1318694-2014-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    April 9, 2014
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIN HOLE IN THE FIRST BALLOON AND THE BURST IN THE SECOND BALLOON WERE BOTH IN THE SAME EXACT LOCATION ON THE BALLOON WHICH LEADS US TO BELIEVE THAT THE HEAVILY CALCIFIED VALVE LED TO THE HOLE IN THE BALLOON AND THE BALLOON BURST. THE SAMPLE CATHETER THAT WAS TESTED FOR RBP WAS TAKEN UP TO 3.5 ATM BEFORE BURST OCCURRED. THE LABELED RBP FOR THIS CATHETER IS 2.0 ATM. THE PHYSICIAN DID NOT DO THIS WHEN RESISTANCE WAS MET. HE USED FURTHER FORCE ON THE BALLOON CATHETER AND CAUSED THE DISTAL PART OF THE BALLOON TO SEPARATE FROM THE REST OF THE CATHETER.

    Description of Event or Problem · 1

    A TYSHAK II CATHETER WAS INSERTED IN A VERY CALCIFIED VALVE AREA. IT PIN HOLED. A SECOND TYSHAK II WAS THEN INSERTED INTO THE SAME VERY CALCIFIED VALVE AREA AND BURST. THE SECOND TYSHAK II WAS DIFFICULT TO REMOVE THROUGH A TERUMO 9FR SHEATH. ON FURTHER FORCE TO REMOVE THE BALLOON, THE DISTAL PART OF THE BALLOON CAME AWAY AS WELL AS THE DISTAL SHAFT IN THE PT. THE PT APPEARED WELL ACCORDING TO THEY PHYSICIAN AND LEFT IN SITU. NO FURTHER INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216235 TYSHAK PERCUTANEOUS VALVULOPLASTY CATHETER DQY NUMED, INC. 105 TT-9536

    Patients

    Seq Age Sex Outcome Treatment
    1