BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GHOST II CATHETER

    MDR report key: 2222929 · Received August 10, 2011

    Report

    Report Number
    9618000-2011-00012
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CATHETER IS ONLY APPROVED FOR A PTA INDICATION. IT WAS BEING USED FOR DIALYSIS. NO OTHER INFORMATION WAS AVAILABLE FOR THIS COMPLAINT OTHER THAN IT WAS BEING USED OFF LABEL.

    Description of Event or Problem · 1

    BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GHOST II CATHETER PTA CATHETER LIT NUMED CANADA, INC. 505 AII-5169

    Patients

    Seq Age Sex Outcome Treatment
    1