BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6858323 · Received September 12, 2017

    Report

    Report Number
    1820334-2017-02953
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    September 10, 2009
    Report Date
    October 26, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE FOLLOWING FIELDS ARE UPDATED. ADVERSE EVENT OR PRODUCT PROBLEM: FROM PRODUCT PROBLEM TO ADVERSE EVENT AND PRODUCT PROBLEM. DATE OF EVENT. RELEVANT TESTS/LABORATORY DATA: IVC FILTER RETRIEVAL REPORT, CT SCANS, X-RAY, MEDICATIONS. PMA/510K: K072240. 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, "TULIP, TILT, VC PERFORATION, EMBEDMENT, UNABLE TO RETRIEVE, BACK PAIN." 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). CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: ADVERSE EVENT TO PRODUCT PROBLEM, SERIOUS INJURY TO MALFUNCTION. 510(K) K032426 NOT RESOLVED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2009. IT IS ALLEGED THAT THE PLAINTIFF WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 09/19/2017 AS FOLLOWS: PATIENT RECEIVED AN IMPLANT ON (B)(6) 2009 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO BILATERAL LEG PAIN AND SWELLING SECONDARY TO ACUTE DEEP VEIN THROMBOSIS. PATIENT EXPERIENCES VENA CAVA PERFORATION, EMBEDMENT AND THAT THE DEVICE IS ABLE TO BE RETRIEVED. PATIENT ALLEGES DEVICE TILT AND BACK PAIN DUE TO THE DEVICE. RETRIEVAL WAS ATTEMPTED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638386 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other