BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-MED II CATHETER

    MDR report key: 1604561 · Received February 8, 2010

    Report

    Report Number
    1318694-2010-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    December 4, 2009
    Report Date
    February 4, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    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 PTV INDICATION. THE REPORTER STATED THAT THE DEVICE WAS BEING USED TO INFLATE A PALMAZ STENT DURING A AAA GRAFT PROCEDURE. THIS DEVICE IS ONLY APPROVED FOR PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY. THIS DEVICE IS A 28MM BALLOON AND NUMED DOES NOT KNOW OF ANY PALMAZ STENT THAT CAN BE INFLATED TO THAT DIAMETER.

    Description of Event or Problem · 1

    CATHETER BALLOON BURST WHILE TRYING TO INFLATE A PALMAZ STENT WHILE PERFORMING A AAA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED II CATHETER PTV CATHETER LIT NUMED, INC. 305 ZZ-2893

    Patients

    Seq Age Sex Outcome Treatment
    1