BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-MED II CATHETER

    MDR report key: 23389645 · Received October 27, 2025

    Report

    Report Number
    1318694-2025-00008
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 27, 2025
    Manufacturer
    NUMED, INC.
    Product Code
    OZT
    PMA / PMN Number
    K122012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED SO THE COMPLAINT COULD NOT BE 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 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. A COMPARATIVE CATHETER WAS PULLED AND TESTED. THE DEVICE WAS THE SAME BALLOON DIAMETER AS THE COMPLAINT CATHETER, BUT A DIFFERENT CATALOG AND 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 10 ATM, WHICH IS DOUBLE THE LABELED RATED BURST PRESSURE OF 5 ATM. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED DUE TO THE LACK OF INFORMATION. NO ROOT CAUSE ESTABLISHED AS THE COMPLAINT COULD NOT BE CONFIRMED. DUPLICATION OF THE ISSUE REQUIRED THE BALLOON TO BE TAKEN TO DOUBLE THE LABELED RATED BURST PRESSURE. ADDITIONAL QUESTIONS WERE SENT TO THE USER FACILITY / DISTRIBUTOR, BUT NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    AS PER THE USER FACILITY / DISTRIBUTOR - TEAM MEMBERS REPORTED THE BALLOON TIP RUPTURED DURING THE PROCEDURE AND BROKE OFF. THE PATIENT HAD TO RECEIVE AN ADDITIONAL PROCEDURE TO REMOVE THE FOREIGN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427801 Z-MED II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER OZT NUMED, INC. 305 ZZ-16925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention