BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 7291036 · Received February 22, 2018

    Report

    Report Number
    1820334-2018-00546
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Report Date
    April 4, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    PMA / PMN Number
    K072240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #3002808486-2017-01881. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. IMPLANT DATE: IMPLANT RECEIVED AND/OR AROUND (B)(6) 2012. (B)(4). THE 510 (K) K072240 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'TULIP - UNABLE TO BE RETRIEVED, PAIN, SWELLING, BRUISING, INSOMNIA, UNABLE TO PERFORM BASIC ACTIVITIES'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. UNKNOWN IF THE REPORTED ABDOMINAL PAIN, SWOLLEN VEINS, BRUISING OF ABDOMEN, INSOMNIA, INABILITY TO EXERCISE, INABILITY TO PERFORM BASIC ACTIVITIES, AND INABILITY TO BE INTIMATE ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Description of Event or Problem · 1

    ¿[PT] ALLEGEDLY RECEIVED AN IMPLANT AND/OR AROUND (B)(6) 2012 VIA THE RIGHT JUGULAR VEIN DUE TO PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS. [PT] IS ALLEGING DEVICE UNABLE TO BE RETRIEVED. [PT] FURTHER ALLEGES ABDOMINAL PAIN, SWOLLEN VEINS, BRUISING OF ABDOMEN AND INSOMNIA, UNABLE TO EXERCISE AND PERFORM BASIC ACTIVITIES, NOT ABLE TO BE INTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133035 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33017 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1