BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-MED¿

    MDR report key: 21630582 · Received March 18, 2025

    Report

    Report Number
    21630582
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    March 4, 2025
    Report Date
    March 5, 2025
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE DEPLOYING THE Z-MED BALLOON INSIDE THE VALVE IT RUPTURED. IT WAS THEN WRAPPED AROUND THE WIRE IN THE PATIENT. THE PHYSICIAN WAS ABLE TO PULL THE BALLOON OUT WITH DIFFICULTY, AND THE SHEATH IN THE GROIN WAS BENT DURING THE EXTRACTION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823429 Z-MED¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT B BRAUN INTERVENTIONAL SYSTEMS, INC 611806 Z-8956/18405054

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male