BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 1337352 · Received February 27, 2009

    Report

    Report Number
    3003502395-2009-00004
    Event Type
    Death
    Date Received
    February 27, 2009
    Date of Event
    February 18, 2009
    Report Date
    March 6, 2009
    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

    DATE SENT: 03/06/2009. INFORMATION OF THIS EVENT WAS REPORTED TO THE COMPANY BY A FIELD PERSONNEL. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME BY THE ACCOUNT. ADDITIONAL MODEL NUMBERS INVOLVED IN THIS EVENT ARE: EML2, MID1, MCR1, AND MAX1. THE ASSOCIATED CATALOG NUMBERS ARE: EML2 - A000467, MID1 - A000195, MCR1 - A000475, AND MAX1-A000163. THE ASSOCIATED LOT NUMBERS AND EXPIRATION DATES FOR THE ADDITIONAL MODEL NUMBERS INVOLVED ARE: EML2-LOT 15283, EXPIRATION DATE: 03/03/2011. MID1 - LOT 15859, EXPIRATION DATE 05/01/2010. MCR1 - LOT 17219, EXPIRATION DATE 10/01/2011. MAX1 - LOT 17230, EXPIRATION DATE 10/01/2011. ADDITIONAL DEVICE MANUFACTURE DATES: EML2 - 03/2008, MID1 - 05/2008, MCR1 - 10/2008, AND MAX1 - 10/2008. EVALUATION SUMMARY - THE DEVICE INVOLVED IN THE EVENT WERE NOT RETURNED FOR EVALUATION. A RETAINED SAMPLE OF EACH DEVICE FROM A SIMILAR LOT OR THE SAME LOT WAS EVALUATED. THE SAMPLE WAS EVALUATED FOR FUNCTIONALITY. THERE WERE NO ISSUES NOTED FOR THE FUNCTIONALITY OF THE DEVICE. ALSO, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A MAZE PROCEDURE, THE PATIENT WENT INTO RENAL DECLINE AND WAS SEPTIC AFTER A "VERY LONG" CASE. THE PATIENT NEVER RECOVERED AND EXPIRED TWELVE (12) DAYS POST OP. THE SURGEON INDICATED THAT THE PATIENT WAS AN OBESE, MALE, WITH LONG-STANDING ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE BIPOLAR SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION GEI ATRICURE, INC. EMR2 17222

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death