BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIDUCIAL MARKER KIT

    MDR report key: 1876311 · Received October 14, 2010

    Report

    Report Number
    MW5017774
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    May 24, 2010
    Report Date
    October 10, 2010
    Manufacturer
    CIVCO
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR VATS WEDGE PROCEDURE, HAD CT-GUIDED MARKING OF NODULE WITH FIDUCIAL DEVICE. ONE OF THE MARKERS DISAPPEARED AND WAS SUSPECTED OF BEING IN THE LAD. CARDIOLOGY CONSULTED AND FLUOROSCOPY REVEALED TO HAVE LODGED IN DISTAL LAD. PATIENT WAS CLINICALLY STABLE AND HAD NO CHEST PAIN. PATIENT SURGERY WAS POSTPONED AND PLACED ON COUMADIN FOR OBSERVATION. REMAINED ASYMPTOMATIC AND SENT HOME ON BABY ASA. SHE WILL BE FOLLOWED BY A CARDIOLOGIST. DIAGNOSIS OR REASON FOR USE: MARKING FOR A SMALL LUNG NODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDUCIAL MARKER KIT NONE NEU CIVCO MT-NW-887-825 100324-09

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other