BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 1773597 · Received July 28, 2010

    Report

    Report Number
    3003502395-2010-00006
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 3, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K063630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE MODEL NUMBERS AND CATALOG NUMBERS OF THE ATRICURE DEVICES INVOLVED IN THE INITIAL PROCEDURE ARE: EML2 - A000467, MAX5 - A000625, AND MCR1 - A000475. THE ACTUAL LOT NUMBERS AND EXPIRATION DATES FOR EACH OF THE DEVICES IS NOT KNOWN AT THIS TIME. INFO OF THIS EVENT WAS REPORTED TO THE COMPANY BY FIELD PERSONNEL. NO FURTHER INFO HAS BEEN PROVIDED AT THIS TIME BY THE ACCOUNT. THE 510(K) NUMBERS FOR EACH DEVICE: EML2 - K063630, MAX5 - K050459, AND MCR1 - K073605. THE ACTUAL LOT NUMBERS OF THE DEVICES USED DURING THE INITIAL PROCEDURE ARE NOT KNOWN AT THIS TIME. THEREFORE, THE MFG DATES ALSO ARE NOT KNOWN.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON (B)(6) 2010, BLEEDING WAS OBSERVED (LAA) AND THE PT WAS CONVERTED TO AN OPEN STERNOTOMY. THE PHYSICIANS REPAIRED THE TEAR AND THE PT WAS RELEASED FROM THE HOSPITAL APPROX SEVEN (7) DAYS POST-OP. ATRICURE DEVICES MAX5, EMR2, EML2, AND MCR1 WERE USED DURING THE PROCEDURE. ON (B)(6) 2010, IT WAS CONFIRMED THROUGH A CONVERSATION WITH AN ATRICURE EMPLOYEE THAT OUR PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT AND THE BLEEDING WAS IN THE LEFT ATRIUM, NOT THE LAA. ON (B)(6) 2010, THE PT WAS RE-ADMITTED FOR PERICARDITIS AND WAS RE-OPERATED TO DRAIN THE FLUID AND THEN SENT HOME. ON (B)(6) 2010, THE PT HAD A STROKE AND WAS RE-ADMITTED TO THE HOSPITAL. UPON EVAL, BLEEDING WAS DISCOVERED AND IT WAS REPORTED THAT A FISTULA HAD OCCURRED IN THE ESOPHAGUS. IT COULD NOT BE DETERMINED HOW THE FISTULA OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE BIPOLAR SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION GEI ATRICURE, INC. EMR2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening