BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST LOCALIZATION NEEDLE

    MDR report key: 2546696 · Received April 20, 2012

    Report

    Report Number
    1036710-2012-00005
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 18, 2010
    Report Date
    April 3, 2012
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    GDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED IS BASED OFF INFO SUPPLIED BY THE PT. ALLEGEDLY AN ANGIOTECH MEDICAL DEVICE TECHNOLOGIES BREAST LOCALIZATION NEEDLE WAS USED. THE PART AND LOT NUMBER INFO IS UNK. THE WIRE USED WENT THROUGH THE CHEST WALL AND INTO THE LUNG. DUE TO UNK INFO WE ARE UNABLE TO CONFIRM. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    DURING THE NEEDLE LOCALIZATION PROCESS, THE WIRE WAS INADVERTENTLY INSERTED THROUGH THE CHEST WALL AND INTO THE LUNG. THE PT WAS TAKEN TO THE OPERATING ROOM FOR EXCISION OF BREAST TISSUE AND THE WIRE COULD NOT BE LOCATED AND REMOVED DUE TO THE MISPLACEMENT OF THE WIRE. THE PT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO LOCATE AND REMOVE THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST LOCALIZATION NEEDLE BLN GDF ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention