BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 1231588 · Received November 14, 2008

    Report

    Report Number
    3002808486-2008-00020
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING FILTER REPLACEMENT ON A FEMALE IN HER 30'S IN 2008, THE PHYSICIAN WAS READY TO PLACE THE FILTER VIA FEMORAL APPROACH. WHEN HE WENT TO UNSHEATHE THE FILTER, THE LEGS DID NOT DEPLOY. THE PHYSICIAN THEN GOT ANOTHER FILTER AND THE SAME THING HAPPENED AGAIN (3002808486-2008-00021). THE PHYSICIAN RETRIEVED BOTH FILTERS VIA JUGULAR APPROACH AND THEN DEPLOYED A TULIP IVC JUGULAR FILTER FOR THE PATIENT. THE FILTER WAS BEING PLACED DUE TO A SCHEDULED GASTRIC BYPASS. THE PATIENT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2193730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention