BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6282331 · Received January 27, 2017

    Report

    Report Number
    3002808486-2017-00183
    Event Type
    Death
    Date Received
    January 27, 2017
    Report Date
    January 4, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). MANUFACTURER REPORT 3002808486-2017-00183 WILL BE CLOSED/CANCELLED AS THE PATIENT DID NOT RECEIVE A GUNTHER TULIP FILTER, MANUFACTURED BY COOK MEDICAL BUT A CELECT FILTER. THIS EVENT WILL BE HANDLED UNDER THE MANUFACTURER REPORT # 3002808486-2017-00182. 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

    ADDITIONAL INFORMATION RECEIVED 11MAY2017: ONLY A CELECT FILTER WAS IMPLANTED ON (B)(6) 2014. MEDICAL RECORDS CONFIRM THAT THE PLAINTIFF WAS IMPLANTED WITH A CELECT FILTER ON (B)(6) 2014 AND THAT NO OTHER FILTERS WERE IMPLANTED.

    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

    MANUFACTURER REF# (B)(4). THE 510(K) K090140. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE, OR UNCHANGED. PATIENT CODE : DEATH (1802) (LISTED IN IFU). PATIENT CODE : PULMONARY EMBOLISM (1498) (LISTED IN IFU). DEVICE CODE 1 MIGRATION OF DEVICE OR DEVICE COMPONENT (1395) (NOT LISTED IN IFU). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT/GUNTHER TULIP FILTER ON (B)(6) 2014." 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

    IT IS ALLEGED THAT ON (B)(6) 2014, VIA RIGHT COMMON FEMORAL VENOUS ACCESS, A "CELECT TULIP" IVC FILTER WAS DEPLOYED IN THE RIGHT GROIN. PATIENT WAS ADMITTED TO ER ON (B)(6) 2015, WHERE HE EXPIRED. ESTATE ALLEGES PATIENT SUFFERED FATAL PULMONARY EMBOLISM DUE TO DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65233 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death