BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 1695731 · Received May 20, 2010

    Report

    Report Number
    3003502395-2010-00004
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 17, 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). (B) (4). INFORMATION OF THIS EVENT WAS REPORTED TO THE COMPANY BY FIELD PERSONNEL. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME BY THE ACCOUNT. AT THIS TIME, THE ACTUAL LOT NUMBER OF THE EML2 DEVICE INVOLVED IS UNKNOWN. PURCHASE RECORDS WERE EVALUATED TO DETERMINE THE MOST RECENT PURCHASE OF EML2 DEVICES PRIOR TO THE CASE. THE MOST RECENTLY PURCHASED EML2 LOT NUMBER WAS 20859 - EXPIRATION DATE 09/01/2010, MANUFACTURE DATE 09/2009. EVALUATION SUMMARY: THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A RETAINED SAMPLE OF THE EML2 DEVICE FROM A SIMILAR 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

    DURING A PROCEDURE, THE PULMONARY VEIN WAS NICKED WHILE USING THE EML2 CLAMP. THE SURGEON NOTICED THE BLEEDING AFTER POSITIONING THE RED RUBBER CATHETER AROUND THE PULMONARY VEINS. HE CONVERTED TO A STERNOTOMY AND REPAIRED THE TEAR, BUT SEVERAL UNITS OF BLOOD WERE REQUIRED. THE PT WAS NOT RESPONDING AFTER BEING TRANSFERRED FROM THE OPERATING ROOM AND IS CURRENTLY ON LIFE SUPPORT. THE SURGEON INDICATED THAT THIS INCIDENT WAS NOT DEVICE RELATED AND THAT THE PT'S ANATOMY PLAYED A ROLE IN THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE BIPOLAR SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION GEI ATRICURE, INC. EML2 20859

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening