BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT VENA CAVA FILTER

    MDR report key: 1051200 · Received May 22, 2008

    Report

    Report Number
    3002808486-2008-00006
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 25, 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

    EVAL: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    VENA CAVA FILTER WAS PLACED INTO A FEMALE PT IN 2008 FOR PREVENTION OF RECURRENT PE. A FILTER RETRIEVAL WAS PERFORMED ON THREE WEEKS LATER; HOWEVER, THE PT EXPERIENCED PAIN AND REVIEW OF IMAGES INDICATED THE FILTER LEGS TO BE OUTSIDE 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR