BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRONTAL SINUS MINI-TREPHINE SET

    MDR report key: 1045336 · Received May 14, 2008

    Report

    Report Number
    1045254-2008-00009
    Event Type
    Injury
    Date Received
    May 14, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    KBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS DESCRIBED IN DISCUSSIONS WITH THE DOCTOR. ABNORMAL OR UNUSUAL VARIATION IN PT'S ANATOMY CAUSED THE EVENT AND, THEREFORE, IT WAS NOT NECESSARY TO EVALUATE THE DEVICE. SUCCESSFUL REVISION PROCEDURE WAS PERFORMED THREE DAYS LATER. AT THAT TIME, THE DOCTOR REPORTED THAT THE PT'S VISION WAS NEARLY NORMAL.

    Description of Event or Problem · 1

    EVENT OCCURRED IN PT BEING TREATED FOR SEVERE AFS (ALLERGIC FUNGAL SINUSITIS) AND SMALL LEFT ORBITAL MUCOCELE. IRRIGATION THROUGH THE MINITREPHINE WAS INITIALLY UNEVENTFUL WITH FUNGAL DEBRIS MOVEMENT AND THE FLUORESCEIN STAINED SALINE MOVING NORMALLY. AFTER 20CC IRRIGATION PLACED AND IRRIGATED, THERE WAS NO FLOW THROUGH THE NOSE. NOTED LEFT EYE BULGING, DID A LATERAL CANTHOTOMY/CANTHOLYSIS AND MEDIAL DECOMPRESSION. SUSPECT A LARGE BLOOD OF FUNGAL DEBRIS BLOCKED THE IRRIGATION OUTFLOW TRACT, AND PATH OF LEAST RESISTANCE BECAME THE INTRAORBITAL ROUTE. ORBITAL EXPLORATION SHOWED FLUORESCEIN STAINED SALINE IN SUPERO-MEDIAL COMPARTMENT, CT SHOWED SUPERO-LATERAL FLUID COLLECTION IN ORBIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRONTAL SINUS MINI-TREPHINE SET SINUS TREPHINATION INSTRUMENT SET KBF MEDTRONIC XOMED, INC. 1892000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention