BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH

    MDR report key: 14986041 · Received July 12, 2022

    Report

    Report Number
    3002808486-2022-00887
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    July 8, 2022
    Report Date
    October 10, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002037738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K211874. INVESTIGATION IS STILL IN PROGRESS. 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

    MANUFACTURER REF# (B)(4). AFTER A SECOND REVIEW OF THE COMPLAINT IT WAS DISCOVERED THAT THE DEIVCE IS NOT SIMILAR TO THE DEVICE MARKETED UNDER PMA/510(K): K211874. THEREFORE THIS EVENT IS NO LONGER REPORTABLE TO FDA. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE SHEATH WAS PLACED INSIDE THE PATIENT BY JUGULAR APPROACH. AFTER THAT, WHEN THE FILTER CATHETER WAS ADVANCED THROUGH THE SHEATH, THE SHEATH BECAME KINKED, WHICH MADE IT DIFFICULT TO CONTINUE TO ADVANCE THE FILTER CATHETER. THEREFORE, THE DEVICE SET WAS REPLACED WITH A GUNTHER FEM APPROACH DEVICE AND THE APPROACHING POINT WAS CHANGED FROM JUGULAR TO FEMORAL. PATIENT OUTCOME: THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT GUNTHER FEM WITH NO PROBLEM. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293604 GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E4006679 10827002037738

    Patients

    Seq Age Sex Outcome Treatment
    1 Female