BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 8185751 · Received December 20, 2018

    Report

    Report Number
    1820334-2018-03796
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Report Date
    February 12, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION. INVESTIGATION :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 ¿TILT, PAIN". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. UNKNOWN IF THE REPORTED PAIN IS DIRECTLY RELATED TO THE FILTER. 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. 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

    NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    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. THE PREVIOUS MDR WAS SUBMITTED BY (FORMER MANUFACTURER) UNDER MANUFACTURER REPORT REFERENCE # 3002808486-2018-01349. 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 #. (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) 2013 VIA THE RIGHT COMMON FEMORAL VEIN POST DEEP VEIN THROMBOSIS (DVT)/ PULMONARY EMBOLISM (PE) DIAGNOSIS. PATIENT ALLEGES TILT. PATIENT STATES, "I GO TO [REDACTED] PAIN MANAGEMENT FOR MULTIPLE ISSUES. I'M IN SO MUCH PAIN, I DON'T KNOW WHICH TO ATTRIBUTE TO THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023066 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 3422918 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1