BEUDAMED
    FDA Adverse Event Death Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 13830957 · Received March 20, 2022

    Report

    Report Number
    9710452-2022-00013
    Event Type
    Death
    Date Received
    March 20, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 18, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    DURING A LEFT ATRIAL APPENDAGE (LAA) IMPLANT PROCEDURE, A NRG TRANSSEPTAL NEEDLE (BAYLIS MEDICAL COMPANY INC.) WAS USED TO COMPLETE THE INITIAL TRANSSEPTAL PUNCTURE OF AN ANEURYSMAL SEPTUM. FOLLOWING SUCCESSFUL TRANSSEPTAL PUNCTURE, THE PHYSICIAN PROCEEDED WITH THE LAA IMPLANT PROCEDURE WITH A WATCHMAN IMPLANT DEVICE (BOSTON SCIENTIFIC CORPORATION). DUE TO CHALLENGING ANATOMY OF THE LAA, THE WATCHMAN DEVICE WAS UNABLE TO BE IMPLANTED AND THE PROCEDURE WAS EVENTUALLY ABORTED WITH THE PATIENT IN STABLE CONDITION. OVERNIGHT, THE PATIENT'S CONDITION WAS REPORTED TO WORSEN. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE PERFORATION TO THE DESCENDING AORTA WAS NOTED AND REPAIRED. ADDITIONAL INFORMATION WAS REQUESTED FROM BOSTON SCIENTIFIC, AND IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2022. THE PHYSICIAN INDICATED THAT THE PATIENT HAD AN AORTIC DISSECTION FROM THE AORTIC ARCH TO THE DIAPHRAGM AND ALTHOUGH UN-AWARE OF THE ORIGIN, THE CAUSE WAS NOT BELIEVED TO BE RELATED TO THE TRANSSEPTAL OR WATCHMAN IMPLANT PROCEDURE. THERE IS NO EVIDENCE THAT REASONABLY 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
    532682 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R