BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 3850712 · Received March 20, 2014

    Report

    Report Number
    1820334-2014-00093
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE WHITE TORQUING HANDLE BROKE OFF, DETACHING THE SNARE, MAKING THE SNARE LOOSE IN THE SHEATH. THE PHYSICIAN USED A HEMOSTAT TO REMOVE THE SNARE FROM THE SHEATH. ANOTHER / DIFFERENT SNARE WAS ALREADY OPENED. THAT SNARE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166721 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK