BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYSHAK II VALVULOPLASTY CATHETER

    MDR report key: 19806914 · Received July 23, 2024

    Report

    Report Number
    1318694-2024-00004
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 23, 2024
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    UDI-DI
    04046964339172
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER OF DEVICES. A REVIEW WAS ALSO PERFORMED ON THE BALLOON TUBING USED TO MANUFACTURE THE BALLOONS USED ON THIS DEVICE. NO OTHER COMPLAINTS WERE ASSOCIATED WITH THE TUBING USED TO MANUFACTURE THE BALLOONS. REVIEW OF DATA FROM THE USER FACILITY SHOWS THAT THE DEVICE WAS BEING USED OFF-LABEL FOR AORTIC VALVULOPLASTY. THIS CATHETER IS ONLY APPROVED FOR PULMONARY VALVULOPLASTY. IT IS UNKNOWN AS TO WHAT PRESSURE THE BALLOON WAS TAKEN TO AND WHAT PRESSURE THE BALLOON BURST AT. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED, HOWEVER, THE FACILITY STATES THAT THEY DO NOT MONITOR THE PRESSURE. INSTEAD, THEY VISUALIZE HOW WELL THE BALLOON EXPANDS UNDER FLUOROSCOPY. THE FOLLOWING WARNING IS LISTED IN THE IFU - "CAUTION: 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." A COMPARATIVE CATHETER WAS PULLED AND TESTED. THE DEVICE WAS THE SAME CATALOG NUMBER BUT FROM A DIFFERENT LOT NUMBER. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED UNTIL IT FAILED. THE COMPARATIVE CATHETER BALLOON DID NOT BURST UNTIL 4 ATM, WHICH IS DOUBLE THE LABELED RATED BURST PRESSURE OF 2 ATM.

    Description of Event or Problem · 0

    DURING A VALVULOPLASTY, THE BALLOON RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479475 TYSHAK II VALVULOPLASTY CATHETER PERCUTANEOUS TRANSLUMINAL VALULOPLASTY CATHETER LIT NUMED, INC. 105 TT-19526 04046964339172

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization