BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATOR SYNERGY CLAMP

    MDR report key: 2954207 · Received July 20, 2007

    Report

    Report Number
    3003502395-2007-00005
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    May 26, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K063630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO UNK ABOUT ACTUAL DEVICE INVOLVED IN EVENT. THE MOST RECENTLY USED PRODUCT WAS LOT NUMBER 10365. EXP DATE = 01/31/2010. MFG DATE: 03/2007, FOR THE MOST RECENTLY USED LOT NUMBER. EVAL SUMMARY: THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVAL SO A RETAINED SAMPLE WAS EVALUATED. THE RETAINED SAMPLE WAS EVALUATED FOR FUNCTIONALITY AND NO ISSUES WERE NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR 10365 AND NO ANOMALIES WERE NOTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITH NO ISSUES NOTED DURING INITIAL PROCEDURE. APPROXIMATELY 30 MINUTES TO 1 HR POST-OPERATIVELY, THE PT WAS RETURNED TO THE OPERATING ROOM DUE TO BLEEDING. A SMALL AMOUNT OF BLEEDING WAS FOUND ON THE LEFT SIDE OF THE HEART. WHEN THE LEFT SIDE WAS MANIPULATED TO REPAIR THE BLEEDING SITE WITH A STITCH, THE SITE EXPANDED AND BYPASS WAS NEEDED IN ORDER TO REPAIR. ONCE THE BLEEDING WAS CONTROLLED, THE PT WAS RETURNED TO RECOVERY. APPROXIMATELY 5-6 HRS AFTER THE REOPERATION, THE PT BEGAN BLEEDING AGAIN FROM BEHIND THE RIGHT SIDE OF THE HEART. ANOTHER REOPERATION WAS PERFORMED TO CONTROL THE BLEEDING. THE BLEEDING WAS CONTROLLED AND PT RECOVERED WITHOUT FURTHER INCIDENT. IN BOTH CASES, THE SURGEON WAS UNSURE OF THE EXACT LOCATION OF THE BLEEDING DUE TO POOR VISIBILITY. THE HOSP STAY WAS PROLONGED AND APPROXIMATELY 30 UNITS, BETWEEN BLOOD PRODUCTS AND CLOTTING FACTORS, WERE ADMINISTERED TO THE PT. THE PT HAS BEEN RELEASED FROM THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLATOR SYNERGY CLAMP BIPOLAR CLAMP GEI ATRICURE, INC. OLL2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention