BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11060678 · Received December 22, 2020

    Report

    Report Number
    9710452-2020-00061
    Event Type
    Injury
    Date Received
    December 22, 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 1 PATIENT EXPERIENCED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS IN A CRYOABLATION PROCEDURE WHERE THE NRG TRANSSEPTAL NEEDLE WAS USED AMONG OTHER DEVICES. THE OTHER DEVICES INCLUDED SL0 SHEATH (ST. JUDE MEDICAL), 20 MM CIRCULAR MAPPING CATHETER (LASSO, BIOSENSE WEBSTER), 15F STEERABLE SHEATH (FLEXCATH ADVANCE, MEDTRONIC), SPIRAL MAPPING CATHETER (ACHIEVE, MEDTRONIC), AND SECOND GENERATION CRYOBALLOON (ARCTIC FROST ADVANCE, MEDTRONIC). 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] MIYAZAKI, S., TANIGUCHI, H., HACHIYA, H., NAKAMURA, H., TAKAGI, T., HIRAO, K., & IESAKA, Y. (2016). DURABILITY OF CRYOTHERMAL PULMONARY VEIN ISOLATION - CREATING CONTIGUOUS LESIONS IS NECESSARY FOR PERSISTENT ISOLATION. INT J CARDIOL, 220, 395-399. DOI:10.1016/J.IJCARD.2016.06.211.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523852 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R