BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 3820540 · Received April 10, 2014

    Report

    Report Number
    3002808486-2014-00010
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT DATE: ACCORDING TO COMPLAINANT THE FILTER AND FRACTURED PIECE OF PRIMARY LEG WILL NOT BE RETRIEVED. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: DEVICE INITIALLY PLACED SUCCESSFULLY ON (B)(6) 2011. URETER PENETRATION NOTED IN 2012, CAUSING THE PATIENT TO RETURN PERIODICALLY TO FLUID DRAINAGE. ON (B)(6) 2014, A PRIMARY LEG FRACTURE WAS NOTED UPON A PERIODIC FLUID DRAINAGE. FILTER WILL NOT BE RETRIEVED. FRACTURED PIECE OF PRIMARY LEG IS ASYMPTOMATIC AND WILL NOT BE RETRIEVED. PATIENT OUTCOME: THE PATIENT NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216255 COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2696981

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR