BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-MED II

    MDR report key: 353466 · Received September 25, 2001

    Report

    Report Number
    1318694-2001-00004
    Event Type
    Other
    Date Received
    September 25, 2001
    Report Date
    September 25, 2001
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    "DURING DILATATION OF THE RE-STENOSIS OF THE LEFT SUBCLAVIAN VEIN OF THE PATIENT WHO HAS A STENT IMPLANTED A YEAR AGO, THE BALLOON WAS PERFORATED AT NOMINAL WORKING PRESSURE WHILE IT WAS BEING INFLATED BY USE OF AN INJECTOR. THE BALLOON WAS BURST INTO TWO PIECES AND THE SHAFT OF THE BALLOON STUCK TO THE GUIDEWIRE AND IT WAS NOT SEPARATED FROM GUIDEWIRE EASILY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43412 Z-MED II PTA CATHETER LIT NUMED, INC. 305 ZZ-0979

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other