BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROBLATE SYSTEM

    MDR report key: 10497474 · Received September 4, 2020

    Report

    Report Number
    3009970070-2020-00076
    Event Type
    Death
    Date Received
    September 4, 2020
    Date of Event
    July 31, 2020
    Report Date
    September 4, 2020
    Manufacturer
    MONTERIS MEDICAL
    Product Code
    GEX
    UDI-DI
    00816589021080
    PMA / PMN Number
    K193375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM. THE PATIENT WAS REMOVED FROM THE MRI AND PLACED ON A STRETCH FOR TRANSPORT TO ICU. THE PATIENT THEN BECAME HEMODYNAMICALLY UNSTABLE REQUIRED ACUTE MEDICAL SUPPORT. THE PATIENT HAD A PERIOD OF PULSE-LESS ELECTRICAL ACTIVITY (PEA) AND RECEIVED CPR WITH RETURN OF SPONTANEOUS CIRCULATION (ROSC). THE PATIENT WAS THEN TRANSFERRED TO THE NEUROLOGICAL ICU WITH REPEAT EPISODES OF PEA WITH CPR AND ROSC. AN EMERGENT ECHOCARDIOGRAM WAS PERFORMED THAT DEMONSTRATED SIGNIFICANTLY DECREASED RIGHT HEART FUNCTION. A CLINICAL DIAGNOSIS OF MASSIVE PULMONARY EMBOLUS WAS MADE. THE PATIENT THEN REQUIRED AN EMERGENT SURGERY FOR A PULMONARY ARTERY THROMBECTOMY WHICH REMOVED A SIGNIFICANT CLOT. THE PATIENT DID NOT TOLERATE STERNUM CLOSURE AND WAS TRANSFERRED TO CARDIOTHORACIC SURGERY ICU IN CRITICAL CONDITION. THE PATIENT WAS MANAGED IN THE ICU FOR MULTIORGAN FAILURE WHICH REQUIRED CONTINUAL RENAL REPLACEMENT THERAPY AS WELL AS CONTINUALLY REQUIRED VERY HIGH DOSE VASOPRESSOR SUPPORT. THE PATIENT RETURNED TO THE OPERATING ROOM FOR STERNUM CLOSURE AFTER FOUR DAYS FOLLOWING THE PULMONARY THROMBECTOMY. THE PATIENT'S MULTIORGAN FAILURE CONTINUED TO WORSEN WITH ACCOMPANYING NEUROLOGICAL DETERIORATION OF UNRESPONSIVENESS, LACK OF SPONTANEOUS MOVEMENT, AND WORSENING BRAIN STEM REFLEXES. THE PATIENT THEN EXPIRED ON (B)(6) 2020. THE SITE REPORTED EMBOLISM WAS POSSIBLY RELATED TO THE NEUROBLATE PROCEDURE AND SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960046 NEUROBLATE SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL 20980 00816589021080

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R