BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP AND GUIDE

    MDR report key: 17760324 · Received September 15, 2023

    Report

    Report Number
    3011706110-2023-00030
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 14, 2023
    Report Date
    September 15, 2023
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    UDI-DI
    30840143904800
    PMA / PMN Number
    K210477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - THE PRODUCT HISTORY RECORD WAS REVIEWED FOR LOT 130635. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A FEMALE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT SURGERY WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION USING ATRICURE OLH CLAMP. WHILE POSITIONING THE CLAMP, BLOOD WAS OBSERVED, AND A TEAR WAS IDENTIFIED AT THE BASE OF THE LEFT ATRIAL APPENDAGE. DUE TO APPENDAGE MORPHOLOGY AS WELL AS INJURY LOCATION AND MINIMAL EXTENT OF BLEEDING, THE SURGEON WAS ABLE TO NON-EMERGENTLY CROSS-CLAMP THE AORTA, AFTER WHICH HE ELECTED TO EXCISE AND OVER SEW THE LEFT ATRIAL APPENDAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTEDLY DOING WELL IN THEIR RECOVERY. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290570 ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP AND GUIDE ISOLATOR® SYNERGY¿ ENCOMPASS CLAMP AND GUIDE OCL ATRICURE, INC. OLH 130635 30840143904800

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R