BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 3812658 · Received April 30, 2014

    Report

    Report Number
    9710452-2014-00004
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. PERFORATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE.

    Description of Event or Problem · 1

    PERICARDIAL EFFUSION OCCURRED IN PT UNDERGOING A PROCEDURE TO STENT THE SEPTUM TO CREATE AN ATRIAL SEPTAL DEFECT TO TREAT HYPERTENSION IN LEFT ATRIUM. THE FIRST RF APPLICATION WITH THE NRG TRANSSEPTAL NEEDLE WAS SUCCESSFUL BUT LEFT HEART ACCESS WAS LOST. THE SEPTUM WAS NOTED BY THE PHYSICIAN TO BE VERY ELASTIC. A SECOND RF APPLICATION WAS APPLIED AND ARTERIAL PRESSURE WAS OBSERVED. CONTRAST INJECTED INDICATED PUNCTURE SITE WAS INADVERTENTLY MADE IN THE AORTA. PERICARDIAL EFFUSION WAS CONFIRMED ON TRANSOESOPHAGEAL ECHOCARDIOGRAPHY. ADDITIONAL INTERVENTION WAS REQUIRED TO RESOLVE THE PROBLEM. AT THE TIME OF REPORTING, THE PT WAS REPORTED TO BE DOING WELL AND WAS OUT OF INTENSIVE CARE. THE INCIDENT IS A KNOWN ADVERSE EVENT IDENTIFIED IN THE DEVICE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258996 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL CO., INC. NRG-71-C0 NGFA150312

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other