BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP VENA CAVA FILTER

    MDR report key: 1003395 · Received February 22, 2008

    Report

    Report Number
    3006332832-2008-00003
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    December 21, 2007
    Report Date
    February 22, 2008
    Manufacturer
    B BRAUN MEDICAL SAS
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VENATECH LP FILTER WAS IMPLANTED IN A MALE IN 2007. THE PHYSICIAN AT ANOTHER HOSPITAL NOTIFIED A BIS SALE REP THAT THE FILTER WAS DISTORTED AND MANGLED. ITS PHYSICAL PROPERTIES WERE IN DISARRAY. THE FILTER HAS MOVED TO THE PT'S LIVER. THE PT HAD ANOTHER PULMONARY EMBOLISM AND WAS SCHEDULED FOR A PULMONECTOMY. IMPORTER NARRATIVE: EXACT PT AGE, PT WEIGHT, AND DEVICE LOT NUMBER ARE NOT AVAILABLE. THE FILTER IS BELIEVED TO STILL BE IMPLANTED IN THE PT. DEVICE IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENATECH LP VENA CAVA FILTER VENA CAVA FILTER DTK B BRAUN MEDICAL SAS 40DLP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O