BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH

    MDR report key: 9144060 · Received October 2, 2019

    Report

    Report Number
    3002808486-2019-01562
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 8, 2019
    Report Date
    October 2, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002037731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K) K172557. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: SHEATH OF IGTCFS-65-JP-JUG-TULIP GOT DAMAGED BY THE FILTER. THE FILTER WAS RETRIEVED BY GTRS-200-RB BUT THE GTRS WAS ALSO DAMAGED. THE FILTER WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION RECEIVED 19SEP2019: IVC FILTER PLACEMENT WAS PERFORMED AND ACCESS WAS GAINED FROM THE RIGHT JUGULAR VEIN. WHEN THE PHYSICIAN WAS ADVANCING THE INTRODUCER SHEATH IN THE BODY, THE PHYSICIAN FELT RESISTANCE AND THE SHEATH KINKED. THE SHEATH GOT DAMAGED BUT THE PHYSICIAN CONTINUED USING THE SHEATH AND IT REACHED DESIRED POSITION. THEN, THE FILTER CATHETER WAS DELIVERED THROUGH THE SHEATH. DURING THE DELIVERY, THE FILTER LEG WAS CAUGHT BY THE KINK AND THE LEG PERFORATED THE SHEATH BUT THE PHYSICIAN CONTINUED USING THE SHEATH AND FILTER. THE FILTER REACHED THE DESIRED POSITION AND THE PHYSICIAN DEPLOYED THE FILTER BUT IT WAS DEPLOYED IN TILTED ANGLE. THEREFORE, GTRS-200-RB WAS USED TO CORRECT THE ANGLE. SNARE CATHETER OF GTRS-200-RB ADVANCED THROUGH THE KINKED SHEATH AND CORRECTED THE ANGLE. FILTER PLACEMENT WAS SUCCEEDED SO THE USER ATTEMPTED TO REMOVE THE SNARE CATHETER TO OUTSIDE THE BODY BUT THE SNARE CATHETER WAS CAUGHT BY THE KINK AND THE SNARE CATHETER SHAFT GOT DAMAGED(BEND). THE PHYSICIAN SOMEHOW REMOVED THE SNARE CATHETER FROM THE BODY AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939392 GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E3532637 00827002037731

    Patients

    Seq Age Sex Outcome Treatment
    1