BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 1680152 · Received May 11, 2010

    Report

    Report Number
    3003502395-2010-00003
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    April 19, 2010
    Report Date
    May 6, 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). INFO OF THIS EVENT WAS REPORTED TO THE COMPANY BY FIELD PERSONNEL. NO FURTHER INFO HAS BEEN PROVIDED AT THIS TIME BY THE ACCOUNT. EVAL SUMMARY - THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVAL. A RETAINED SAMPLE OF THE OLL2 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 RIGHT INFERIOR PULMONARY VEIN WAS DISSECTED AND THREE ABLATIONS WERE COMPLETED USING THE OLL2 DEVICE. IT WAS NOTICED THAT THERE WAS BLEEDING NEAR THE PULMONARY VEIN. THE SURGEON RE-INTUBATED THE PT AND A TEAR WAS FOUND ON THE INFERIOR WALL OF THE PULMONARY VEIN. THE SURGEON COULD NOT DISCERN HOW THE TEAR WAS CREATED. THE TEAR WAS REPAIRED BY SUTURE AND THERE WAS NO LONG TERM PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE BIPOLAR SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION GEI ATRICURE, INC. OLL2 22316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention