BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 10296524 · Received July 20, 2020

    Report

    Report Number
    9618000-2020-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    January 30, 2020
    Report Date
    July 20, 2020
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO NUMED CANADA, INC. AND THE BALLOON BURST WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. A REVIEW OF THE BALLOON MATERIAL USED SHOWED THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS BALLOON MATERIAL LOT NUMBER USED. TWO COMPARATIVE CATHETERS FROM DIFFERENT LOTS WERE PULLED AND TESTED FOR RATED BURST PRESSURE. THE LABELED RBP FOR THIS DEVICE IS 3.0 ATM. THE FIRST COMPARATIVE CATHETER WAS INFLATED UNTIL FAILURE. THE DEVICE WAS TAKEN TO RBP (3.0 ATMS) WITH NO ISSUES. IT WAS THEN OVER INFLATED TO 4.5 ATMS, WHICH IS GREATER THAN THE RBP, WHERE IT BURST LONGITUDINALLY. THE SECOND COMPARATIVE CATHETER WAS ALSO INFLATED UNTIL FAILURE. THE DEVICE WAS TAKEN TO RBP (3.0 ATMS) WITH NO ISSUES. IT WAS THEN OVER INFLATED TO 5.0 ATMS, WHICH IS ALSO GREATER THAN THE RBP, WHERE IT BURST LONGITUDINALLY.

    Description of Event or Problem · 1

    AS PER THE INCIDENT REPORT FROM SWISSMEDIC - "BALLOON RUPTURE, HORIZONTAL, AT 2.5". SERIOUS CONSEQUENCES OR POSSIBLE SERIOUS CONSEQUENCES FOR PATIENT - "NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764097 TYSHAK II CATHETER PTV CATHETER LIT NUMED CANADA, INC. 105 TH-35391

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR