BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7259272 · Received February 9, 2018

    Report

    Report Number
    1820334-2018-00389
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Report Date
    March 22, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    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 'GUNTHER TULIP - DEVICE UNABLE TO BE RETRIEVED, PAIN'. 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 PAIN IN THE STOMACH AND RIGHT LEG IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #3002808486-2017-02112. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE INTERNAL JUGULAR VEIN DUE TO BLOOD CLOTS. PT IS ALLEGING THE DEVICE UNABLE TO BE RETRIEVED. PT IS FURTHER ALLEGING PAIN IN THE STOMACH AND RIGHT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102221 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1