BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS.

    MDR report key: 4172552 · Received October 10, 2014

    Report

    Report Number
    3003502395-2014-00014
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 11, 2014
    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). THE DEVICE WAS IMPLANTED AND NOT AVAILABLE FOR RETURN. NO DEVICE HISTORY REVIEW WAS PERFORMED AS LOT NUMBER WAS NOT UNABLE TO BE ASCERTAINED. BASED ON THE INFORMATION RECEIVED THE ISSUE WAS POSSIBLY CAUSED BY MISPLACEMENT OF THE CLIP AS A RESULT OF ANATOMICAL/HUMAN FACTOR ISSUES. UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WHO HAD UNDERWENT LEFT-SIDED ABLATION AND PLACEMENT OF A PRO140 ON THE LAA THREE WEEKS PRIOR, RETURNED FOR RIGHT-SIDED ABLATION. UPON PERFORMING A TEE IT WAS OBSERVED THAT THERE WAS A CLOT IN THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS PUT ON BYPASS, THE CLOT WAS RETRIEVED, RIGHT-SIDED ABLATION WAS PERFORMED AND THE LAA WAS OVERSEWED. IT WAS NOTED THAT THE PRO140 CLIP HAD NOT BEEN PLACED AT THE BASE OF THE LAA ALLOWING FOR CONTINUED FLOW AND POSSIBLY CONTRIBUTING TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642695 ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS. CLIP, IMPLANTABLE FZP ATRICURE, INC. PRO140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention