BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE

    MDR report key: 2423441 · Received January 13, 2012

    Report

    Report Number
    1625425-2011-00160
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Report Date
    January 9, 2012
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DQX
    PMA / PMN Number
    PRE-AMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILLED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT STAFF NOTICED DURING THE PROCEDURE THAT THE GUIDEWIRE WAS MISSING THE FLOPPY END. AN IMMEDIATE SEARCH OF THE SURGICAL FIELD AND SURROUNDING AREA WAS CONDUCTED. UNDER THE GUIDANCE OF FLUOROSCOPY, SMALL INCISIONS WERE MADE BY THE DOCTOR TO IMMEDIATELY REMOVE THE WIRE FROM THE PATIENT. THE PIECE OF GUIDEWIRE WAS LOCATED IN THE PATIENT'S LEFT LOWER LEG. IT WAS THEN COMPARED TO AN IDENTICAL WIRE. ANOTHER FLUORO WAS TAKEN OF THE LEFT LOWER LEG. THE FLUOROSCOPY WAS NEGATIVE FOR ANY FOREIGN BODY (GUIDEWIRE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE GUIDEWIRE DQX ARGON MEDICAL DEVICES INC. NA 99772907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other