BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIFUNCTIONAL LINEAR PEN

    MDR report key: 6986441 · Received October 30, 2017

    Report

    Report Number
    3011706110-2017-00094
    Event Type
    Death
    Date Received
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K130521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    A PATIENT HAD A STANDARD THORASCOPIC MAZE/BILATERAL PV ISOLATION WITH MLP1 AND ENDOCLAMP IN (B)(6) 2016 WITH NO PROCEDURAL DIFFICULTIES/COMPLICATIONS POST PROCEDURE AND WAS DISCHARGED THE NEXT DAY. ONE MONTH POST-OP, THE PATIENT WAS SEEN IN THE CLINIC FOR FOLLOW UP AND WAS WELL BUT 2 DAYS LATER, THE PRESENTED TO A LOCAL HOSPITAL WITH MENINGEAL SYMPTOMS AND THEN WAS DISCHARGED HOME AND RE-PRESENTED A FEW DAYS LATER AND WAS ADMITTED. THE PATIENT HAD A SUBSEQUENT FIT AND CARDIAC ARREST. THE PATIENT WAS TRANSFERRED BACK TO (B)(6) AND WAS DIAGNOSED WITH PHLEGMON IN THE LA WHERE HE WAS TAKEN BACK TO THE THEATRE WHERE A PATCH WAS PUT TO THE BACK OF THE LA WITH ENDOSCOPY AND WHILE THE AORTA WAS CROSS CLAMPED, A 1CM HEALED TEAR IN THE ESOPHAGUS WAS SEEN. THE PATIENT LEFT WITH A NEUROLOGICAL DEFICIT WHICH CONTINUED THROUGH RECOVERY WHICH WAS A SLOW RECOVERY. A FEW MONTHS LATER THE PATIENT WAS ADMITTED WITH SEPSIS FROM WHICH HE DID NOT RECOVER FROM. THE EXACT DATE OF DEATH WAS UNABLE TO BE OBTAINED FROM SURGEON AND THE CAUSE OF DEATH WILL BE DETERMINED DURING AN INQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768439 MULTIFUNCTIONAL LINEAR PEN MULTIFUNCTIONAL LINEAR PEN OCL ATRICURE, INC. MLP1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ENDOCLAMP