BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7134978 · Received December 20, 2017

    Report

    Report Number
    1820334-2017-04655
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Report Date
    June 28, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

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

    PATIENT ALLEGEDLY RECEIVED ON (B)(6) 2011 DUE TO DEEP VEIN THROMBOSIS. PATIENT ALLEGES LONG TERM IMPLANT HAS CAUSED EMOTIONAL DISTRESS.

    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. 20 DEVICES IN LOT. NO RELEVANT NOTES ON WO FOR NEITHER DEVICE (IGTCFS-65-FEM) LOT# E2699711 (2689125), NOR FILTER TULIP LOTS# E2665647 AND E2666890. NO OTHER COMPLAINTS ON LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO A44118 (DEVICE MI), 1000384QC (DEVICE QCI), A41935 (TULIP MI), A41936 (TULIP QCI). 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

    INVESTIGATION ¿ INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. UNKNOWN IF THE REPORTED EMOTIONAL DISTRESS IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS TIME. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: EMOTIONAL DISTRESS. 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2011. 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
    912684 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 2689125 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other