BEUDAMED
    FDA Adverse Event Death Summary report: N

    WOLF LUMITIP DISSECTOR

    MDR report key: 2950897 · Received February 8, 2013

    Report

    Report Number
    3003502395-2013-00001
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ATRICURE, INC.
    Product Code
    FTD
    PMA / PMN Number
    K111020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS DISCARDED BY THE FACILITY.DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION HOWEVER DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCE OR RE-WORK NOTED DURING MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A TT MAZE PROCEDURE WHEN THE DOCTOR WAS DISSECTING AROUND THE PV WITH THE MID1 DEVICE IN THE OBLIQUE SINUS, THE LUNG UNEXPECTEDLY INFLATED CAUSING THE SURGEON TO QUICKLY REMOVE THE DISSECTOR. AS THE SURGEON WAS EXTRACTING THE DISSECTOR HE INADVERTENTLY CREATED A HOLE IN THE BACK WALL OF THE ATRIUM. THE SURGEON CONVERTED TO A STERNOTOMY TO GAIN BETTER ACCESS AND CONTROL THE BLEEDING AND CUT THE SVC WITH THE SAW UPON OPENING THE CHEST. THE PATIENT EXPIRED THREE DAYS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54384 WOLF LUMITIP DISSECTOR LAMP, SURGICAL FTD ATRICURE, INC. MID1 39413

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death