BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

    MDR report key: 6965830 · Received October 20, 2017

    Report

    Report Number
    3011706110-2017-00091
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K142084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO DEVICE MALFUNCTION REPORTED, DEVICE FUNCTIONED AS EXPECTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO DEVICE HISTORY REVIEW WAS DONE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A PATIENT HAD A CONVERGENT PROCEDURE ON (B)(6) 2017 AND WAS ENROLLED IN THE CONVERGE TRIAL. ON (B)(6) 2017, SHE PRESENTED TO THE ER WITH WORSENING BILATERAL EDEMA/WEEPING AND PAIN FOR 2 DAYS. THE PATIENT CONFIRMED WORSENING SOB OVER SHORTER DISTANCES BUT HER BAD KNEES RESTRICTED HER MOBILITY AS WELL AND HER FAMILY REPORTED THAT HER "BREATHING SOUNDS WET" OVER THE LAST TWO DAYS. A CT SCAN SHOWED PLEURAL EFFUSION, PERICARDIAL EFFUSION (BUT NOT >1CM AND NOT CONSISTENT WITH TAMPONADE PHYSIOLOGY), AND PERICARDITIS. REPEAT TRANSTHORACIC ECHOCARDIOGRAM PERFORMED ON (B)(6) 2017 SHOWED NO TAMPONADE BUT ELEVATED RAP, AND A SEPTAL SHUDDER WITH SUSPECTED SOME EFFUSIVE CONSTRICTIVE PHYSIOLOGY, ABOUT THE SAME AS (B)(6) 2017. ON (B)(6) 2017 CARDIOLOGY WAS CONSULTED AND THE FOLLOWING DIAGNOSIS INCLUDED ACUTE PERICARDITIS SECONDARY TO EPICARDIAL AND ENDOCARDIAL ABLATION PROCEDURE, CLINICALLY ASSOCIATED HEART FAILURE MOST CONSISTENT WITH EFFUSIVE CONSTRICTIVE PERICARDITIS WITH PERIPHERAL EDEMA PRESUMABLY RELATED TO DIASTOLIC HEART FAILURE WITH SOME DYSPNEA, ALONG WITH SMALL PERICARDIAL EFFUSION WITH PROBABLE FIBRINOUS EXUDATE, AND LEFT AND RIGHT PLEURAL EFFUSION. THE SUBJECTS CONDITIONS IMPROVED AND ON (B)(6) 2017 WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745989 EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX OCL ATRICURE, INC. CDK-1413 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R