BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 18237579 · Received November 30, 2023

    Report

    Report Number
    2124215-2023-64330
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 30, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    UDI-DI
    00685447000211
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NRF RF NEEDLE WAS SELECTED FOR USE DURING A WATCHMAN PROCEDURE. PHYSICIAN WAS DRAGGING THE NRG NEEDLE FROM SUPERIOR VENA CAVA INTO SEPTUM. THEN, PATIENT WENT INTO ASYSTOLE. COMPRESSIONS STARTED. A TEMPORARY PACEMAKER WAS INSERTED. THUS, THE WATCHMAN PROCEDURE CONTINUED AND IT WAS COMPLETED SUCCESSFULLY. THE TEMP PACEMAKER WAS LEFT IN PLACE. NO OTHER PATIENT COMPLICATIONS WERE NOTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). THE PATIENT IS FULLY RECOVERED. THE CURRENT STATUS IS UNKNOWN. NO ISSUE WAS NOTED WITH THE NRG NEEDLE. THE SEPTUM WAS CROSSED WITH NO ISSUES AFTER THE INTERVENTION. THERE WERE TWO ATTEMPTS TO CROSS THE SEPTUM, AND RF WAS APPLIED ONCE, WITH THE SAME NRG NEEDLE. NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY WAS NOTED. IN THE PHYSICIANS OPINION, THE DEVICE CONTRIBUTES TO THE PATIENT COMPLICATION, SINCE THE PATIENT WENT ASYSTOLE WHEN TRYING TO CROSS THE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137281 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC. NGFD140323 00685447000211

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Life Threatening| R