BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-MED CATHETER

    MDR report key: 1707158 · Received May 25, 2010

    Report

    Report Number
    1318694-2010-00003
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 25, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K991977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS BEING USED OFF LABEL FOR AN UNAPPROVED INDICATION. THIS DEVICE IS LABELED AND 510(K) CLEARED FOR A PTA/PTV INDICATION. THE DEVICE IS SUPPOSED TO BE RETURNED TO NUMED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE PHYSICIAN STATES THAT THE BALLOON CAUGHT ON ONE OF THE STENTS CAUSING IT TO BURST.

    Description of Event or Problem · 1

    BALLOON BURST DURING PLACEMENT OF A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED CATHETER PTA CATHETER LIT NUMED, INC. 302 Z-4632

    Patients

    Seq Age Sex Outcome Treatment
    1