BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIPP LAA EXCLUSION SYSTEM

    MDR report key: 5003416 · Received August 12, 2015

    Report

    Report Number
    3003502395-2015-00029
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    March 23, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED FOR EVALUATION HOWEVER DEVICE HISTORY RECORD REVIEWED AND NO NON-CONFORMANCE OR REWORK NOTED DURING MANUFACTURING PROCESS THAT WOULD BE RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER DURING A AORTIC ROOT REPLACEMENT WITH PROSTHETIC VALVE, MAZE PROCEDURE WITH LEFT ATRIAL APPENDAGE EXCLUSION. THE PT PRESENTED (B)(6) POST-OP WITH "BLACK MOLD" ENDOCARDITIS, BLACK MOLD STERNAL WOUND AND BLACK MOLD PRESENT ON ALL IMPLANTS. THE PROCEDURE INVOLVED SEVERAL DEVICES FROM DIFFERENT MEDICAL DEVICE MANUFACTURERS. THE FACILITY WAS UNCERTAIN AS TO WHERE THE INFECTION ORIGINAL OR ITS CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529269 ATRICLIPP LAA EXCLUSION SYSTEM ATRICLIPP LAA EXCLUSION SYSTEM FZP ATRICURE, INC. ACH140 55869

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening