BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 16030667 · Received December 21, 2022

    Report

    Report Number
    3019751610-2022-00075
    Event Type
    Injury
    Date Received
    December 21, 2022
    Report Date
    December 21, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE TO SUGGEST THAT THE 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 PROCEDURES, BAYLIS MEDICAL COMPANY HAS DECIDED TO SUBMIT THIS REPORT. THERE IS NO SUSPECTED DEVICE FAILURE.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, AN ARTICLE [1] WAS IDENTIFIED WITH THE FOLLOWING INFORMATION WHERE A BAYLIS MEDICAL COMPANY INC. DEVICE WAS USED FOR TRANSSEPTAL PUNCTURE FOR ABLATION PROCEDURES: DIRECT ORAL ANTI-COAGULANTS AND WARFARIN WERE LEFT UNINTERRUPTED THROUGHOUT THE PERI-PROCEDURAL PERIOD. THE PROCEDURE WAS PERFORMED UNDER MODERATE SEDATION OBTAINED WITH DEXMEDETOMIDINE. A BOLUS OF 5000 U OF HEPARIN WAS ADMINISTERED IMMEDIATELY FOLLOWING VENOUS ACCESS, AND HEPARINIZED SALINE WAS ADDITIONALLY INFUSED TO MAINTAIN AN ACTIVATED CLOTTING TIME OF 300-350 S. A SINGLE TRANSSEPTAL PUNCTURE WAS PERFORMED USING A RADIOFREQUENCY NEEDLE (BAYLIS MEDICAL, MONTREAL, CANADA) WITH OR WITHOUT GUIDE BY INTRACARDIAC ECHOGRAPHY (SOUNDSTAR; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA). PULMONARY VEIN ISOLATION WAS PERFORMED WITH EITHER A CONTACT FORCE-SENSING IRRIGATED-TIP RADIOFREQUENCY CATHETER (SMARTTOUCH SURROUND FLOW; BIOSENSE WEBSTER) INSERTED INTO THE LA VIA A LONG SHEATH (SL0; ST. JUDE MEDICAL) AND GUIDED BY A 3-DIMENSIONAL MAPPING SYSTEM (CARTO3; BIOSENSE WEBSTER), OR A 28-MM SECOND- OR FOURTH-GENERATION CRYOBALLOON (ARCTIC FRONT ADVANCE; MEDTRONIC, MINNEAPOLIS, MN, USA) INSERTED INTO THE LA VIA A 15-FR STEERABLE SHEATH (FLEXCATH ADVANCE; MEDTRONIC). ADDITIONAL SUBSTRATE MODIFICATION WAS PERFORMED ACCORDING TO THE PREFERENCE OF THE OPERATOR. AN ESOPHAGEAL PROBE (SENSITHERM; ST. JUDE MEDICAL OR ESOPHASTAR; JAPAN LIFELINE) WAS USED TO MONITOR LUMINAL ESOPHAGEAL TEMPERATURE IF NECESSARY. THE PROCEDURAL ENDPOINT WAS BIDIRECTIONAL CONDUCTION BLOCK BETWEEN THE LA AND PVS AS VERIFIED BY THE CIRCULAR MAPPING CATHETER, INCLUDING A 30-MIN WAITING TIME FROM THE LAST APPLICATION. ANY ADENOSINE TRIPHOSPHATE PROVOKED DORMANT PV CONDUCTION WAS ELIMINATED BY ADDITIONAL APPLICATIONS... ALL PATIENTS UNDERWENT INITIAL AF ABLATION AND ACHIEVED PV ISOLATION WITHOUT ANY PROCEDURAL COMPLICATIONS EXCEPT FOR 1 PATIENT WITH CARDIAC TAMPONADE. THERE IS NO EVIDENCE TO SUGGEST THAT THE 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 PROCEDURES, BAYLIS MEDICAL COMPANY HAS DECIDED TO SUBMIT THIS REPORT. [1] AOYAMA, D., UZUI, H., SEKIHARA, T., EGUCHI, T., HASEGAWA, K., TSUJI, T., KATAOKA, T., NAGAO, M., KAKEHASHI, S., MUKAI, M., AIKI, T., YAMAGUCHI, J., SHIOMI, Y., TAMA, N., FUKUOKA, Y., ISHIDA, K., & TADA, H. (2022). DECLINES IN SERUM URIC ACID LEVEL AFTER CATHETER ABLATION OF ATRIAL FIBRILLATION. HEART AND VESSELS, 37(12), 2049-2058. HTTPS://DOI.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2918800 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening