BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPI-SENSE ST COAGULATION DEVICE

    MDR report key: 18161872 · Received November 17, 2023

    Report

    Report Number
    3011706110-2023-00049
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 22, 2023
    Report Date
    September 24, 2024
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCM
    PMA / PMN Number
    P200002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY - CORRECTION TO A PREVIOUSLY SUBMITTED MDR FOR IDENTIFIED DISCREPANCIES BETWEEN DATA SUBMITTED IN MDR AND DATA SUBMITTED TO GUDID. D4 - CORRECTION TO MODEL NUMBER.

    Description of Event or Problem · 0

    ON 3-OCT-2023, 64-YEAR-OLD MALE PATIENT UNDERWENT POSTERIOR WALL ABLATION VIA SUB-XIPHOID APPROACH WITH EPI-ST DEVICE. ON (B)(6) 2023 (POD 19), PATIENT PRESENTED TO A DIFFERENT HOSPITAL WITH SYMPTOMS AND DIAGNOSED WITH CARDIAC TAMPONADE. PATIENT UNDERWENT TREATMENT CONSISTING OF PERICARDIAL WINDOW WITH DRAINAGE OF 800ML OF FLUID. PATIENT'S HEMODYNAMICS STABILIZED. PATIENT IF RECOVERING IN ICU. THIS IS A PROCEDURAL COMPLICATION AND THERE IS NO ALLEGED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674025 EPI-SENSE ST COAGULATION DEVICE COAGULATION DEVICE OCM ATRICURE, INC. EPIST UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| L