BEUDAMED
    FDA Adverse Event Death Summary report: N

    CANNULA ACCESSORIES

    MDR report key: 12068675 · Received June 25, 2021

    Report

    Report Number
    3011706110-2021-00035
    Event Type
    Death
    Date Received
    June 25, 2021
    Date of Event
    June 7, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT A HYBRID ABLATION WITH LEFT ATRIAL APPENDAGE (LAA) MANAGEMENT. THE PHYSICIAN INTRODUCED THE SUBTLE CANNULA AND DURING PLACEMENT, THE INFERIOR VENA CAVA (IVC) TORE. THE PROCEDURE WAS CONVERTED THROUGH A MEDIAN STERNOTOMY AND THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS PUMP. THE IVC WAS SUTURED AND THE SURGEON THEN COMPLETED RF ABLATION TO THE PULMONARY VEINS AND WITH EPICARDIAL CRYO ABLATIONS. THE LAA WAS CLOSED WITH AN ACHV45. THE PATIENT HAD SEIZURES POST OP DAY 1 AND BECAME NEUROLOGICALLY COMPROMISED. ON (B)(6) 2021 THE PATIENT EXPIRED. 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
    963336 CANNULA ACCESSORIES CANNULA ACCESSORIES OCL ATRICURE, INC. CANNULA ACCESSORIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death OSL2, ACHV45, CRYO2