BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYSHAK II VALVULOPLASTY CATHETER

    MDR report key: 23381688 · Received October 24, 2025

    Report

    Report Number
    1318694-2025-00007
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 24, 2025
    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
    CA, US
    Reporter Occupation
    OTHER

    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. 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. THE ROOT CAUSE OF THIS FAILURE IS UNKNOWN. THE DEVICE WAS NOT RETURNED SO THE COMPLAINT COULD NOT EVEN BE CONFIRMED. REQUEST FOR THE DEVICE DID NOT RESULT IN THE RETURN OF THE DEVICE. ADDITIONAL QUESTIONS WERE SENT TO THE DISTRIBUTOR / USER FACILITY; HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - DURING SCHEDULED RIGHT HEART CATHETERIZATION AND BALLOON ANGIOPLASTY OF PULMONIC VALVE, TYSHAK II 18.0MMX4.0MM BALLOON INFLATED TO BURST PRESSURE OF 2.0 ATM. BALLOON RUPTURED. TIP OF THE BALLOON SHEARED AWAY FROM BODY OF BALLOON CATHETER AND REMAINED IN BODY AS CATHETER REMOVED. INTRACARDIAC ECHO INITIATED IN ATTEMPT TO VISUALIZE RETAINED BALLOON TIP. UNABLE TO OBTAIN ANY IMAGES. ALTERNATE BALLOON USED TO COMPLETE PROCEDURE. PROCEDURE ENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172915 TYSHAK II VALVULOPLASTY CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER LIT NUMED, INC. 105 TT-21665 04046964339172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other