BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER

    MDR report key: 6976563 · Received October 25, 2017

    Report

    Report Number
    1820334-2017-03689
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Report Date
    August 23, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

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

    OCCUPATION: NON-HEALTH CARE PROFESSIONAL. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    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, ¿GUNTHER TULIP FILTER IMPLANTED." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 25 MAY 2018 AS FOLLOWS: PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2008 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO HISTORY OF PHLEBITIS, HYPERTENSION, DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PT IS ALLEGING FILTER IN PLACE MORE THAN 90 DAYS WITHOUT FURTHER DETAILS. ATTEMPTED RETRIEVALS ARE UNKNOWN AT THIS TIME. PT FURTHER ALLEGES DAILY ANXIETY.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2008. IT IS ALLEGED THAT THE PLAINTIFF 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
    756602 COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE N/A E2059687

    Patients

    Seq Age Sex Outcome Treatment
    1 Other