BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 8515369 · Received April 15, 2019

    Report

    Report Number
    9618000-2019-00002
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 1, 2019
    Report Date
    April 15, 2019
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED AT NUMED (B)(4), INC. THE CATHETER IS INTACT AND ALL COMPONENTS ARE ACCOUNTED FOR. THE BALLOON HAS A BURST THAT IS LONGITUDINAL. A REVIEW OF THE REPORT FROM THE PHYSICIAN SHOWS THAT THIS DEVICE WAS BEING USED OFF LABEL FOR AN UNAPPROVED INDICATION AND WAS ALSO USED WITHOUT AN INFLATION DEVICE WITH PRESSURE GAUGE. THE IFU HAS A WARNING THAT STATES - "DO NOT EXCEED THE RBP. AN INFLATION DEVICE WITH PRESSURE GAUGE IS RECOMMENDED TO MONITOR PRESSURE. PRESSURE IN EXCESS OF THE RBP CAN CAUSE BALLOON RUPTURE AND POTENTIAL INABILITY TO WITHDRAW THE CATHETER THROUGH THE INTRODUCER SHEATH." TWO COMPARATIVE CATHETERS WERE PULLED AND TESTED FOR RATED BURST PRESSURE. BOTH BALLOONS WERE INFLATED WITH ROOM TEMPERATURE WATER TO THE LABELED RBP OF 1.5 ATM WITH NO ISSUES. THE BALLOONS WERE THEN TAKEN ABOVE RBP UNTIL THEY BURST. ONE CATHETER BURST AT 2.0 ATM AND THE OTHER ONE BURST AT 2.5 ATM. BOTH CATHETERS WERE WELL ABOVE THE LABELED RATED BURST PRESSURE.

    Description of Event or Problem · 1

    AS PER THE INCIDENT REPORT SENT TO NUMED (B)(4), INC. FROM THE DISTRIBUTOR - "WE PERFORMED BALLOON AORTIC VALVULOPLASTY WITH TYSHAK 25 X 60 BALLOON DURING RAPID PACING. THE ANNULUS MEASURED 26.5MM. THE BALLOON RUPTURED AFTER 4 SEC OF INFLATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309898 TYSHAK II CATHETER VALVULOPLASTY CATHETER DQY NUMED CANADA, INC. 105 TH-33445

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR