BEUDAMED
    FDA Adverse Event Death Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 14106898 · Received April 13, 2022

    Report

    Report Number
    9710452-2022-00025
    Event Type
    Death
    Date Received
    April 13, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 13, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO OBJECTIVE EVIDENCE THAT SUGGESTS A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Description of Event or Problem · 0

    DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, A NRG TRANSSEPTAL NEEDLE (BAYLIS MEDICAL COMPANY INC.) WAS USED TO COMPLETE THE INITIAL TRANSSEPTAL PUNCTURE (TSP) FOR THE PROCEDURE. THE PHYSICIAN EXPERIENCED DIFFICULTY IMAGING THE SEPTUM. TENTING ON THE SEPTUM WAS EVENTUALLY CONFIRMED AND TSP WAS ATTEMPTED. THE NRG NEEDLE WAS NOT OBSERVED IN THE LEFT ATRIUM. TSP WAS RE-ATTEMPTED AND WAS SUCCESSFUL. WITH NO OBSERVED COMPLICATIONS, THE PHYSICIAN PROCEEDED WITH THE LAAC PROCEDURE USING THE WATCHMAN DEVICES (BOSTON SCIENTIFIC). DURING THE RETRACTION OF THE WATCHMAN SHEATH, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A PERICARDIAL EFFUSION (PE) SWEEP WAS COMPLETED WITH NO PE NOTED. FURTHER INVESTIGATION WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND CHEST X-RAY REVEALED THAT BLOOD WAS POOLING IN THE PLEURAL CAVITY. THE PLEURAL CAVITY WAS DRAINED. THE PATIENT WAS STABILIZED AND WAS MOVED TO THE RECOVERY UNIT. LATER THAT EVENING, THE PATIENT EXPIRED. THERE IS NO OBJECTIVE EVIDENCE THAT SUGGESTS A BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899942 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death