BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATOR SYNERGY CLAMP, LEFT CURVE

    MDR report key: 4873919 · Received June 25, 2015

    Report

    Report Number
    3003502395-2015-00019
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K101174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO ATRICURE FOR EVALUATION IT WAS DISCARDED BY THE HOSPITAL. THE LOT NUMBER OF THE DEVICE WAS UNABLE TO BE ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT DURING A TOTALLY THORACOSCOPIC MAZE PROCEDURE, A HOLE WAS INADVERTENTLY POKED IN THE LEFT SIDE ATRIUM WITH AN EML DEVICE. THE PATIENT WAS PUT ON EMERGENCY BYPASS, AND A STERNOTOMY WAS PERFORMED. THE HOLE WAS PATCHED USING SUTURE AND PLEDGETS TO COMPLETE THE REPAIR. THE PATIENT HAD A DIFFICULT WEEKEND WITH SOME NEUROLOGICAL PROBLEMS, BUT BY MONDAY WAS AWAKE AND ALERT AND IN SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410730 ISOLATOR SYNERGY CLAMP, LEFT CURVE SURGICAL DEVICE ABLATION CARDIAC OCL ATRICURE, INC. EML2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R