BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS.

    MDR report key: 2872942 · Received December 13, 2012

    Report

    Report Number
    3003502395-2012-00010
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT DURING THE PROCEDURE THE SURGEON HAD DIFFICULTY GETTING THE CLIP APPLIER ARTICULATION TO LOCK IN PLACE COMPLETELY. (IT WAS LOCKED IN LEFT AND RIGHT MOVEMENT BUT NOT UP AND DOWN). AFTER TRYING SEVERAL TIMES TO POSITION THE CLIP ON THE LAA, THE SURGEON DECIDED TO USE ANOTHER ATRICLIP DEVICE. WHEN THE 2ND CLIP WAS PLACED THE SURGEON NOTICED SIGNIFICANT BLEEDING FROM THE APPENDAGE AND IT TOOK APPROXIMATELY 30 MINUTES TO CONTROL USING SURGI-CELL AND SUTURE. THE SURGEON ELECTED TO STAPLE OFF THE APPENDAGE. THERE WAS NO LONG-TERM ADVERSE PATIENT CONSEQUENCE OR EXTENDED LENGTH OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS. CLIP, IMPLANTABLE FZP ATRICURE, INC. PRO150 41046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention