BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6435642 · Received March 27, 2017

    Report

    Report Number
    1820334-2017-00656
    Event Type
    Injury
    Date Received
    March 27, 2017
    Report Date
    June 29, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNRESOLVED 510(K) K032426. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    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 "BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSIS WITH THROMBOLYSIS, SHORTNESS OF BREATH, SWELLING, PAIN, AND OTHER ". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. ACCORDING TO DEVICE HISTORY RECORDS, BASED ON THE LOT NUMBER PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS OR THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G., THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA IN THE SITUATIONS DESCRIBED IN THE IFU.

    Description of Event or Problem · 1

    PATIENT WAS ALLEGEDLY TREATED FOR HISTORY OF PULMONARY EMBOLISM AND CLAIMS TO HAVE RECEIVED AN IMPLANT ON (B)(6) 2010. PATIENT IS ALLEGING BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSIS WITH THROMBOLYSIS, SHORTNESS OF BREATH, SWELLING, PAIN, AND OTHER CONTINUING SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218619 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening