BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENATECH - LGM 30D/U VENA CAVA FILTER SYSTEM

    MDR report key: 2757430 · Received December 4, 2007

    Report

    Report Number
    9612452-2007-00001
    Event Type
    Other
    Date Received
    December 4, 2007
    Date of Event
    March 4, 2007
    Report Date
    April 12, 2007
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    DTK
    PMA / PMN Number
    N/A-OUS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILTER AND SYRINGES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER BELIEVES THAT 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.

    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.

    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