BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA RETRIEVAL SET

    MDR report key: 1070939 · Received July 3, 2008

    Report

    Report Number
    1820334-2008-00368
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 6, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN AS LOT# INFORMATION NOT PROVIDED BY REPORTER. EVALUATION: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING A ROUTINE PROCEDURE OF THE GUNTHER TULIP PLACEMENT, THE PHYSICIAN EXPERIENCED SIGNIFICANT DIFFICULTY PULLING THE TULIP INTO THE SHEATH. ONCE THEY APPLIED MORE PRESSURE, THE SNARE BROKE AND THEY WERE UNABLE TO USE IT TO RECAPTURE THE HOOK. THE SNARE WAS REMOVED AND ANOTHER SNARE SET WAS UTILIZED TO REMOVE THE FILTER. THE FILTER WAS RETRIEVED WITH NO INCIDENT AND THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED ON 07/01/2008: THE PATIENT WAS A MID 50'S MALE, WHO IS DOING FINE. THE BROKEN SNARE WAS REMOVED AND A NEW SNARE WAS INSERTED. THE NEW SNARE WAS ABLE TO RETRIEVE THE HOOK AND CAPTURE THE FILTER. THE PATIENT IS DOING FINE, AND HAS NOT BEEN BACK FOR ANY FOLLOW UP IMAGING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK