BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7558059 · Received May 31, 2018

    Report

    Report Number
    1820334-2018-01599
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Report Date
    July 17, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #: 3002808486-2018-00446. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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 RETRIEVE, PAIN, ANXIETY". 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 IS DIRECTLY RELATED TO THE FILTER. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. NO RELEVANT NOTES ON NEITHER DEVICE OR LOT NUMBER. NO OTHER COMPLAINTS ON LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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 ON (B)(6) 2012 VIA THE [VEIN LISTED IN THE PPF/PPS] DUE TO DEEP VEIN THROMBOSIS FOLLOWING SERIOUS MOTORCYCLE ACCIDENT. PT IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED. PT. FURTHER ALLEGES PAIN AND ANXIETY. THERE WERE NO REPORTS OF ATTEMPTED RETRIEVAL.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400721 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 2855062 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1