BEUDAMED
    FDA Adverse Event Death Summary report: N

    THD EVOLUTION US

    MDR report key: 3680040 · Received March 1, 2014

    Report

    Report Number
    3006680097-2014-00001
    Event Type
    Death
    Date Received
    March 1, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 28, 2014
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K070815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A CONVERSATION BETWEEN (B)(6) SALES REP AND THE ANESTHESIOLOGIST OF THE SECOND THD CASE, THE PT WAS KNOWN TO HAVE HEART PROBLEMS. (B)(6). THD SPA MADE THREE ATTEMPTS TO DIRECTLY CONTACT THE DOCTOR AND GATHER FIRST HAND RELATED INFO: FIRST ATTEMPT - (B)(4) 2014 4:35PM (CET), (B)(4), AT THE PRESENCE OF (B)(4)). DR. (B)(6) WAS BUSY WITH PTS AT THE (B)(6). SECOND ATTEMPT - (B)(4) 2014 5:15PM (CET),(B)(4), AT THE PRESENCE OF (B)(4). DR. (B)(6) WAS BUSY WITH PTS AT THE (B)(6). THIRD ATTEMPT -(B)(4) 2014 (EST), (B)(4), DR. (B)(6) WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A SCHEDULED THD CASE, REGULARLY PROCEEDING, THE SURGEON WAS WARNED BY THE ANESTHESIOLOGIST ABOUT A HEART PROBLEM RELATED TO THE PT. THE THD CASE WAS SUSPENDED SINCE CHEST COMPRESSION PROCEDURE WAS INITIATED TO SUPPORT THE PT. NEVERTHELESS, THE PT DIED. THE SURGEON REFERRED THAT THE DEATH WAS NOT CAUSED BY THE THD CASE. FIFTY MINUTES LATER, A SECOND SCHEDULED THD CASE STARTED AT THE SAME FACILITY WITH ANOTHER SURGEON. THIS SECOND CASE WAS SUCCESSFULLY TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125683 THD EVOLUTION US EVOLUTION US AND SLIDE ONE KIT JAF THD SPA 700016A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death