BEUDAMED
    FDA Adverse Event Death Summary report: N

    THROMCAT

    MDR report key: 1545906 · Received November 24, 2009

    Report

    Report Number
    1721279-2009-00055
    Event Type
    Death
    Date Received
    November 24, 2009
    Date of Event
    November 4, 2009
    Report Date
    November 4, 2009
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS NOTIFICATION OF AN ADVERSE EVENT WHICH OCCURRED IN AFOREIGN COUNTRY. INDICATION FOR THE PROCEDURE: TOTAL OCCLUSION OF THE LAD. PROCEDURE: THE PT, OF UNK SEX AND AGE PRESENTED WITH AN ACUTE MI, CARDIOGEN SHOCK AND WAS VERY UNSTABLE AT THE TIME OF THE PROCEDURE TO OPEN A TOTAL OCCLUSION IN THE LAD. A SPNC THROMBECTOMY DEVICE WAS USED IN ORDER TO SUCCESSFULLY REDUCE A LARGE THROMBUS BURDEN. AFTER STENTING WITH DRIVER 2.5 / 18 THE PT BECAME MORE AND MORE UNSTABLE. EXTERNAL CHEST COMPRESSION WAS PERFORMED BUT WAS NOT SUCCESSFUL. THE EVENT WAS NOT RELATED TO ANY ISSUE OR MALFUNCTION OF THE SPNC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT EMBOLECTOMY / THROMBECTOMY CATHETER DXE SPECTRANETICS CORP. 63000-02 82260

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death