BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6529073 · Received April 28, 2017

    Report

    Report Number
    3002808486-2017-01034
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    December 8, 2014
    Report Date
    August 17, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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). B1) CORRECTED FROM PRODUCT PROBLEM TO ADVERSE EVENT. (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) CORRECTED PMA/510(K) # FROM K090140 TO K043509. H1) CORRECTED FROM MALFUNCTION TO SERIOUS INJURY. H11) CORRECTIONS TO B1, G5 AND H1. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION. 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.

    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). A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. B3) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D4) LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. D6) (B)(6) 2011. F9) UNKNOWN AS LOT# IS UNKNOWN. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. H4) UNKNOWN AS LOT# IS UNKNOWN. (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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 WAS RECEIVED ON 024/18/2017 AS FOLLOWS: THE PLAINTIFF ALLEGEDLY RECEIVED DEVICE IMPLANT ON (B)(6) 2011 FOR PREVENTION OF BLOOD CLOT INJURY AFTER MYOCARDIAL INFARCTION AND MASSIVE BILATERAL PE. THE PLAINTIFF ALLEGES DEVICE MIGRATION, DEVICE TILT, VENA CAVA PERFORATION, BLEEDING, MIGRATION OF IVC FILTER AND EROSION THROUGH THE CAVA, AND 4 PERFORATED TINES AFTER IMPLANT OF DEVICE.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2011." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310682 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening