BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6224399 · Received January 5, 2017

    Report

    Report Number
    3002808486-2016-01593
    Event Type
    Injury
    Date Received
    January 5, 2017
    Report Date
    April 28, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. ALL INFORMATION FOR THIS EVENT WAS PREVIOUSLY SUBMITTED FROM (B)(6)2017-(B)(6)2017.

    Additional Manufacturer Narrative · 0

    D. 6) CORRECTION. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC. 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.

    Description of Event or Problem · 0

    THIS ADDITIONAL INFORMATION RECEIVED ON 02/03/2017 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT FEMORAL INFRARENAL DUE TO PREVENTION OF BLOOD CLOTS AFTER MAJOR AUTO ACCIDENT. PLAINTIFF ALLEGES A SUCCESSFUL RETRIEVAL SOMETIME IN 2013 (DATE NOT SPECIFIED) DUE TO FILTER TILT AND PUNCTURE OF THE ENDOTHELIAL WALL AND THAT A SECOND UNKNOWN COOK FILTER, WAS PLACED SOMETIME IN 2013 WHICH IS ALLEGED UNABLE TO BE RETRIEVED WITHOUT FURTHER DETAILS. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC"

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A GUNTHER TULIP FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K090140, K112119 OR K121057. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A GUNTHER 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.

    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) 2012". PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2012 " PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7481 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| R