BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULA ACCESSORIES

    MDR report key: 12068643 · Received June 25, 2021

    Report

    Report Number
    3011706110-2021-00034
    Event Type
    Injury
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE (B)(4) UPON RECEIPT, THE CANNULA, LOT NUMBER 107244, WAS VISUALLY AND FUNCTIONALLY INSPECTED PURSUANT TO SPECIFIC ATRICURE INVESTIGATION PROCEDURES. THE COMPLAINT WAS NOT CONFIRMED, CANNULA DID NOT HAVE ANY SHARP EDGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 A (B)(6) YEAR-OLD-FEMALE WITH A HISTORY OF ATRIAL FIBRILLATION AND OBESITY UNDERWENT AN OFF-PUMP STAGED CONVERGENT LEFT PULMONARY VEIN ISOLATION AND LEFT ATRIAL MANAGEMENT (LAAM) PROCEDURE. DURING INITIAL CANNULA INSERTION, THE SUBTLE CANNULA CONTACTED THE INFERIOR VENA CAVA (IVC) AND BLEEDING OCCURRED THAT REQUIRED THE PROCEDURE TO BE CONVERTED TO A STERNOTOMY. THE IVC WAS SUTURED. A LAA040 ATRICLIP WAS PLACED ON THE LAA AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. 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
    961988 CANNULA ACCESSORIES CANNULA ACCESSORIES OCL ATRICURE, INC. CANNULA ACCESSORIES 107244

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R