BEUDAMED
    FDA Adverse Event Death Summary report: N

    CANNULA ACCESSORIES

    MDR report key: 12025321 · Received June 18, 2021

    Report

    Report Number
    3011706110-2021-00031
    Event Type
    Death
    Date Received
    June 18, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 25, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K193162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CANNULA DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE CANNULA DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED. CORRECTED DEVICE INFORMATION SUBMITTED.

    Additional Manufacturer Narrative · 1

    CASE-(B)(4) THE EPI-SENSE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 105998. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCE THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2021 A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT A CONVERGENT PROCEDURE. THE SURGEON SUCCESSFULLY ABLATED THE POSTERIOR WALL OF THE LEFT ATRIUM. AFTER THE ABLATION PROCEDURE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION. EXTERNAL MEANS OF CONVERTING THE PATIENTS RHYTHM FAILED, AND THE PROCEDURE WAS CONVERTED TO A STERNOTOMY TO INTERNALLY MANIPULATE THE HEART BACK INTO SINUS RHYTHM. THERE WERE NO SIGNS OF DAMAGE TO THE HEART ANATOMY FROM THE CONVERGENT PROCEDURE, AND ASSESSMENT DETERMINED THERE WAS SIGNIFICANT BLOCKAGE OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), DESPITE A PREVIOUS STENT. TWO ADDITIONAL STENTS WERE PLACED. FOLLOWING THE SURGICAL INTERVENTION, PATIENT CONDITION DETERIORATED AND THE PATIENT ULTIMATELY PASSED AWAY. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919549 CANNULA ACCESSORIES CANNULA ACCESSORIES OCL ATRICURE, INC. CSK-6130 105998

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death CSK-6130