BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE SYNERGY ABLATION SYSTEM

    MDR report key: 11699420 · Received April 21, 2021

    Report

    Report Number
    3011706110-2021-00016
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCM
    PMA / PMN Number
    P100046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 A FEMALE PATIENT UNDERWENT AN ON-PUMP, HEPARINIZED CORONARY ARTERY BYPASS, PULMONARY VEIN ISOLATION, AND LEFT ATRIAL APPENDAGE MANAGEMENT PROCEDURE. WHEN THE CROSS CLAMP CAME OFF AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THERE WAS BLEEDING, AND A PERFORATION WAS FOUND ON THE LEFT ANTERIOR VEIN IN THREE SEPARATE SPOTS WHERE THE OLL2 WAS USED. THE AREAS OF PERFORATION WERE SUTURED. SURGEON STATED THAT THE PATIENT WAS DOING WELL POST PROCEDURE. THIS WAS A PROCEDURAL COMPLICATION, THERE WAS NO REPORTED DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598858 ATRICURE SYNERGY ABLATION SYSTEM ATRICURE SYNERGY ABLATION SYSTEM OCM ATRICURE, INC. OLL2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention