BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7946637 · Received October 9, 2018

    Report

    Report Number
    1820334-2018-03140
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Report Date
    November 30, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. INVESTIGATION EVALUATION. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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 'TULIP - UNABLE TO RETRIEVE'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. NO RELEVANT NOTES FOUND ON WORK ORDER OR DEVICE LOT. NO OTHER COMPLAINTS ON LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE# 3002808486-2018-01018. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL REPORT, COOK INC. INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER MANUFACTURER REPORT REFERENCE #1820334-2018-03140. INITIAL REPORTER OCCUPATION: NON HEALTHCARE PROFESSIONAL. (B)(4). 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 · 1

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS. THE PATIENT IS ALLEGING THAT THE DEVICE IS UNABLE TO BE RETRIEVED AND MAY CAUSE PROBLEMS IN THE FUTURE SINCE IT CANNOT BE RETRIEVED WITHOUT FURTHER EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789820 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 UNKNOWN 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1