BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH - LGM 30D/U VENA CAVA FILTER SYSTEM

    MDR report key: 893086 · Received July 24, 2007

    Report

    Report Number
    3006332832-2007-00001
    Event Type
    Injury
    Date Received
    July 24, 2007
    Date of Event
    March 4, 2007
    Report Date
    April 11, 2007
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VENA TECH LGM VENA CAVA FILTER WAS INADVERTENTLY PLACED UPSIDE DOWN IN AN INFRARENAL POSITION. THE FILTER MIGRATED TO THE PATIENT'S HEART, AND WAS SURGICALLY EXPLANTED. IMPORTER NARRATIVE: BASED ON INFORMATION PROVIDED BY THE MANUFACTURER THIS EVENT IS LIKELY A RESULT OF PHYSICIAN ERROR. THE MANUFACTURER UTILIZES QUALITY CONTROL STEPS AND SPECIALIZED LOADING EQUIPMENT THAT MAKE IT IMPOSSIBLE FOR THE FILTER TO BE LOADED UPSIDE DOWN DURING PRODUCTION. AS A RESULT, IN ORDER TO PLACE THE FILTER UPSIDE DOWN, USER ERROR IS A CERTAINTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENATECH - LGM 30D/U VENA CAVA FILTER SYSTEM VENA CAVA FILTER DTK B. BRAUN MEDICAL SAS NA F0831760

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention