BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11029160 · Received December 17, 2020

    Report

    Report Number
    9710452-2020-00043
    Event Type
    Injury
    Date Received
    December 17, 2020
    Report Date
    December 17, 2020
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 THROMBOEMBOLIC EVENT OCCURRED IN ATRIAL FIBRILLATION ABLATION PROCEDURES WHERE THE NRG TRANSSEPTAL NEEDLE WAS USED AMONGST OTHER DEVICES INCLUDING 7F DUODECAPOLAR CATHETER, 9F BOSTON SCIENTIFIC ULTRA ICE¿CATHETER, 71-CM ST. JUDE BRK¿, CLOSED-TIP CATHETER (BOSTON SCIENTIFIC BLAZER II¿ OR WEBSTER CELSIUS¿ 8MM, OPEN IRRIGATED-TIP CATHETER (WEBSTER THERMOCOOL¿3.5 MM, ST. JUDE COOL PATH¿, OR SAFIRE-BLU¿4.0 MM), CIRCUMFERENTIAL MAPPING CATHETER (7F WEBSTER LASSO¿ OR ST. JUDE REFLEXION SPIRAL¿) AND ST. JUDE NAVX¿ MAPPING SYSTEM. THE THROMBOEMBOLIC EVENT OCCURRED IN A PATIENT ON WARFARIN WITH A MECHANICAL HEART VALVE. 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 WINKLE R, MEAD R, ENGEL G, ET AL. DISCONTINUING ANTICOAGULATION FOLLOWING SUCCESSFUL ATRIAL FIBRILLATION ABLATION IN PATIENTS WITH PRIOR STROKES. J INTERV CARD ELECTRO PHYSIOL (2013) 38:147-153.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493256 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening