BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMITIP DISSECTOR

    MDR report key: 17791102 · Received September 21, 2023

    Report

    Report Number
    3011706110-2023-00031
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 21, 2023
    Manufacturer
    ATRICURE, INC.
    Product Code
    GDI
    PMA / PMN Number
    K111020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 130632 AND CONTAINS NO INFORMATION THAT INDICATES DEVICES WERE RELEASED WITH ANY NON-CONFORMANCE THAT WOULD CONTRIBUTE TO COMPLAINT.

    Description of Event or Problem · 0

    ON (B)(6) 2023 A 66-YEAR-OLD FEMALE PATIENT UNDERWENT A BI-LATERAL VIDEO-ASSISTED THORACOSCOPIC PULMONARY VEIN ISOLATION WITH LEFT ATRIAL APPENDAGE EXCLUSION. WHILE ROUTING THE MID1 DEVICE A PERFORATION OCCURRED IN THE OBLIQUE SINUS AT THE RIGHT SUPERIOR PULMONARY VEIN. PROCEDURE WAS CONVERTED TO A STERNOTOMY AND THE PERFORATION WAS REPAIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY PATIENT WAS DOING GREAT. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584916 LUMITIP DISSECTOR LUMITIP DISSECTOR GDI ATRICURE, INC. MID1 130632

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| L EMR2.