BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11089502 · Received December 29, 2020

    Report

    Report Number
    9710452-2020-00052
    Event Type
    Injury
    Date Received
    December 29, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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. THERE IS NO SUSPECTED DEVICE FAILURE. 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 ONE PATIENT EXPERIENCE CARDIAC TAMPONADE IN A PULMONARY VEIN ISOLATION PROCEDURE WHERE THE NRG TRANSSEPTAL NEEDLE WAS USED AMONG OTHER DEVICES, INCLUDING CARTO SYSTEM (BIOSENSE WEBSTER), 20-POLE MAPPING CATHETER (BEEAT, JAPAN LIFELINE) AND 20-POLE CIRCULAR MAPPING CATHETER (EPSTAR LIBERO, JAPAN LIFELINE. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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. [1] OHE, M., HARAGUCHI, G., KUMANOMIDO, J., OBUCHI, A., HORI, K., ITO, S., . . . FUKUMOTO, Y. (2019). NEW TAILORED APPROACH USING A REVISED ASSESSMENT OF FRAGMENTED POTENTIALS FOR PERSISTENT ATRIAL FIBRILLATION: EARLY AREA DEFRAGMENTATION BY MODIFIED CFAE MODULE. J CARDIOVASC ELECTROPHYSIOL, 30(6), 844-853. DOI:10.1111/JCE.13888

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555501 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening