BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6328304 · Received February 14, 2017

    Report

    Report Number
    3002808486-2017-00456
    Event Type
    Death
    Date Received
    February 14, 2017
    Report Date
    March 28, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K090140, K112119 OR K121057. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Additional Manufacturer Narrative · 1

    (B)(4). 510(K): K032426. (B)(4).

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2013. PATIENT OUTCOME: [PT] IS DECEASED". HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 03/01/2017 AS FOLLOWS: PATIENT WAS ALLEGEDLY TREATED FOR TUMOR IN LUNG; BLOOD CLOT IN LEG, DVT, PE AND CLAIMS TO HAVE RECEIVED AN IMPLANT ON (B)(6) 2013 A REMOVAL WAS UNSUCCESSFULLY PREFORMED ON (B)(6) 2015, A SECOND FILTER, A BARD DENALI, WAS PLACED ON (B)(6) 2016. PATIENT IS ALLEGING TILT, DEVICE UNABLE TO BE RETRIEVED, BLEEDING, EMBEDDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112287 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death