BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATOR TRANSPOLAR PEN

    MDR report key: 2190136 · Received April 25, 2007

    Report

    Report Number
    3003502395-2007-00004
    Event Type
    Injury
    Date Received
    April 25, 2007
    Date of Event
    March 30, 2007
    Report Date
    April 25, 2007
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    K050459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO IS UNK ABOUT ACTUAL DEVICE INVOLVED IN EVENT. THE MOST RECENTLY USED PRODUCT WAS LOT NUMBER 9906. EVAL SUMMARY: THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVAL, SO A RETAINED SAMPLE WAS EVALUATED. A RETAINED SAMPLE WAS NOT AVAILABLE FROM 9906, SO A SAMPLE WAS TESTED FROM 9971. THE RETAINED SAMPLE WAS EVALUATED FOR FUNCTIONALITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR 9906 AND NO ANOMALIES WERE NOTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEART WAS CARDIOPLEGIC AND PT WAS ON A 2+ HOUR PUMP RUN PRIOR TO CREATING A LESION WITH THE PEN. THE PEN WAS BEING USED FOR THE ISTHMUS LESION TO THE MITRAL VALVE ANNULUS. ONE STAMP LESION WAS PERFORMED AND WENT FINE. THE SECOND STAMP LESION WAS PERFORMED AND A LOUD POP WAS HEARD AND A HOLE WAS CREATED IN THE LEFT ATRIUM. ONE SUTURE WAS USED TO REPAIR INJURY. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND THE PT WAS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLATOR TRANSPOLAR PEN BIPOLAR PEN GEI ATRICURE, INC. MAX1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR