BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT VENA CAVA FILTER

    MDR report key: 1051181 · Received May 22, 2008

    Report

    Report Number
    3002808486-2008-00005
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 25, 2008
    Manufacturer
    WILLIAM COOK EUROPE, APS
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE VENA CAVA FILTER WAS PLACED INTO A MALE PATIENT IN 2008 FOR PREVENTION OF RECURRENT PE. REMOVAL OF THE FILTER WAS CONDUCTED ABOUT 7 DAYS LATER; HOWEVER, IT WAS INDICATED BY THE REPORTER THAT FILTER REMOVAL WAS DIFFICULT, AND REVIEW OF IMAGES REVEALED THE FILTER LEGS TO BE THROUGH THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT VENA CAVA FILTER DTK VENA CAVA FILTER DTK WILLIAM COOK EUROPE, APS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR