BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11023979 · Received December 16, 2020

    Report

    Report Number
    9710452-2020-00039
    Event Type
    Injury
    Date Received
    December 16, 2020
    Report Date
    December 16, 2020
    Manufacturer
    BAYLIS MEDICAL COMPANY 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

    THERE IS NO SUSPECTED DEVICE FAILURE. HOWEVER, AS BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. THIS MDR IS BEING REPORTED ACCORDING TO THE TIMELINES SPECIFIED PER THE FDA GUIDANCE FOR INDUSTRY "POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC" (MAY 2020), FOLLOWING FDA NOTIFICATION OF THE DEFERRED REPORTING.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AN ARTICLE [1] WAS IDENTIFIED IN WHICH NRG TRANSSEPTAL NEEDLE WAS USED TO PUNCTURE THROUGH THE INTERVENTRICULAR SEPTUM, LEADING TO VENTRICULAR TACHYCARDIA. AS PER THE PUBLISHED ARTICLE, THE FIRST RF DELIVERY INDUCED VENTRICULAR TACHYCARDIA, WHICH WAS TERMINATED VIA THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD). THE NRG NEEDLE WAS USED IN COMBINATION WITH OTHER DEVICES DURING THE PROCEDURE INCLUDING A FIRM GUIDEWIRE (AMPLATZ SUPER STIFF, BOSTON SCIENTIFIC, NATICK, MD), A 71-CM DEFLECTABLE 8.5F INNER LUMEN CATHETER SHEATH WITH A TAPERED DILATOR (AGILIS, ST. JUDE MEDICAL, ST. PAUL, MN). THE NRG TRANSSEPTAL NEEDLE IS INDICATED FOR CREATION OF AN ATRIAL SEPTAL DEFECT IN THE HEART. SECONDARY APPLICATIONS INCLUDE TRANSSEPTAL HEART ACCESS, MONITORING INTRACARDIAC PRESSURES, SAMPLING BLOOD, AND INFUSING SOLUTIONS. THE DEVICE WAS USED OFF-LABEL IN THIS CASE TO PUNCTURE THROUGH THE INTERVENTRICULAR SEPTUM. THERE IS NO EVIDENCE OF DEVICE FAILURE. HOWEVER, AS BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. [1] GAMBLE, J. H., BASHIR, Y., RAJAPPAN, K., & BETTS, T. R. (2013). LEFT VENTRICULAR ENDOCARDIAL PACING VIA THE INTERVENTRICULAR SEPTUM FOR CARDIAC RESYNCHRONIZATION THERAPY: FIRST REPORT. HEART RHYTHM, 10(12), 1812-1814. DOI:10.1016/J.HRTHM.2013.07.033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486480 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention