BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 3894111 · Received June 20, 2014

    Report

    Report Number
    1820334-2014-00250
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING IVC DENALI FILTER RETRIEVAL, RIGHT JUGULAR ACCESS ON A (B)(6) MALE PT, AFTER ACCESS WAS GAINED AND THE COOK INTRODUCER SET WAS IN PLACE IN THE VENA CAVA, THE FILTER WAS SUCCESSFULLY SNARED. THE PHYSICIAN TIGHTENED THE SNARE AROUND THE FILTER HOOK AND PROCEEDED TO COVER THE FILTER WITH THE INNER INTRODUCER SHEATH. HE WAS ABLE TO COVER THE FILTER TO A POINT JUST ABOVE THE FEET OF THE FILTER. THE PHYSICIAN THEN TRIED TO COVER THE TRAPPED FILTER WITH THE OUTER INTRODUCER SHEATH BUT THE FILTER GOT STUCK WITH THE FEET OUTSIDE THE SHEATH. WHILE HE ATTEMPTED TO PULL THE FILTER INTO THE INTRODUCER SHEATH, THE PROXIMAL WIRE KNOB BROKE OFF. PLACING A CLAMP ON THE PROXIMAL END OF THE WIRE SNARE THE PHYSICIAN PULLED ON THE WIRE, TRYING TO PULL THE REMAINING PORTION OF THE FILTER INTO THE INTRODUCER SHEATH. WHILE PULLING WITH SOME FORCE, THE WIRE SNARE BROKE. HE PULLED THE WHOLE SYSTEM OUT TO SKIN LEVEL BUT DID NOT WANT TO YANK THE BARE FILTER OUT THROUGH THE VESSEL AND SKIN. THE PHYSICIAN WAS ABLE TO REMOVE THE GTRS SYSTEM COMPLETELY, LEAVING THE FILTER STUCK IN THE PT'S NECK, AND THEN PLACED A CORDIS BRITE TIP SHEATH OVER THE FILTER, SUTURING IT IN PLACE. A VASCULAR SURGERY CONSULT WAS CALLED. THE PT WAS TAKEN TO THE OPERATING ROOM WHERE A VASCULAR SURGEON PERFORMED A FOREIGN BODY REMOVAL PROCEDURE AND THE FILTER WAS ENTIRELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364211 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET FILTER, INTRAVASCULAR, CARDIOVASCULAR DTZ COOK, INC. NA 4706838

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention