BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE

    MDR report key: 2781808 · Received September 28, 2012

    Report

    Report Number
    2781808
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 6, 2012
    Report Date
    September 28, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    OPTEASE IVC FILTER INADVERTENTLY DEPLOYED IN INVERTED DIRECTION. STAFF WAS UNAWARE UNTIL TODAY WHEN PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF SHORTNESS OF BREATH. WORK-UP IN THE ER DISCOVERED FILTER WAS INVERTED AND HAD MIGRATED TO THE SUPERIOR VENA CAVA AND THE RIGHT ATRIUM. THE DEVICE IS LIKE A SMALL HEXAGONAL JUNGLE GYM. IT IS AXIALLY SYMMETRIC BUT NOT LINEARLY. ONE END OF THE AXIS HAS A TINY HOOK FOR RETRIEVAL PURPOSES WHILE SIX TINY AXIALLY PARALLEL STRUTS OFF THE HEXAGONAL PROMINENCES ENGAGE THE WALL OF THE INFERIOR VENA CAVA IF IT TRIES TO MIGRATE. IT IS POSSIBLE TO DEPLOY THE DEVICE VIA THE FEMORAL OR JUGULAR VEIN BUT THE ORIENTATION FOR THE FEMORAL APPROACH IS THE OPPOSITE OF THAT OF THE JUGULAR. THE DELIVERY TUBE THAT HOLDS THE UNEXPANDED FILTER IS MARKED WITH ARROWS FOR THE DIFFERENT APPROACHES. IT APPEARS TO HAVE BEEN DEPLOYED IN THE WRONG ORIENTATION FOR THE APPROACH TAKEN. IT IS NOT KNOWN HOW THIS HAPPENED. THE FILTER WAS SUCCESSFULLY RETRIEVED IN THE CATH LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CORPORATION * 15501864

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NO OTHER THERAPIES