BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 3062896 · Received April 12, 2013

    Report

    Report Number
    3002808486-2013-00007
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 14, 2013
    Report Date
    February 8, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SPECIFIC DATE UNKNOWN AS INFORMATION WAS NOT PROVIDE EXCEPT FOR THE YEAR 2007. DEVICE MANUFACTURE DATE UNKNOWN AS LOT# IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH HEART PALPITATIONS AND ABDOMINAL PAIN TO CLINIC ON (B)(6) 2013. PATIENT CLAIMED SYMPTOMS HAD BEEN TROUBLING FOR SEVERAL MONTHS BUT DECIDED TO SEE A PHYSICIAN ON (B)(6) 2013. IT IS ALLEGED THAT ABDOMINAL CT REVEALED FRACTURED FILTER WITH PIECES THAT HAD MIGRATED. A VENOGRAM ON (B)(6) 2013 REVEALED A LEG OF THE FILTER LODGED IN THE RIGHT VENTRICLE AND AN ARM WAS DISCOVERED IN THE PULMONARY ARTERY, ALSO ANOTHER LEG HAD FRACTURED AND ACTUALLY SHIFTED BELOW THE ORIGINAL PLACEMENT OF FILTER. THE PHYSICIAN ATTEMPTED SEVERAL DIFFERENT APPROACHES AT RETRIEVAL OF THE LEG IN THE PATIENT'S VENTRICLE AND THE FILTER ITSELF. THE FILTER WAS PLACED ORIGINALLY AT THIS SAME FACILITY IN 2007. IT IS ALLEGED THAT ALL ATTEMPTS TO RETRIEVE THE DEVICE AND ITS PIECES WERE UNSUCCESSFUL. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR EP/CARDIOLOGY TO WATCH SYMPTOMS AND CONTEMPLATE OPEN SURGERY TO REMOVE THE PIECE IN THE PATIENT'S HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157555 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2097782

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| L