BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG RF TRANSSEPTAL KIT

    MDR report key: 20953993 · Received December 17, 2024

    Report

    Report Number
    2124215-2024-79788
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 10, 2023
    Report Date
    December 17, 2024
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD B3: DATE OF EVENT WAS UPDATED WITH ESTIMATED DATE AS (B)(6) 2023, SINCE AOI INVOLVES A COHORT OF PATIENTS AND NO SPECIFIC PROCEDURE DATES WERE PROVIDED, DATE OF WHEN AOI WAS PUBLISHED WAS USED AS EVENT DATE. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THIS WAS NOT AVAILABLE BECAUSE THIS WAS RELATED TO A LITERATURE STUDY. ARAI, T., IWASAKI, Y., HAYASHI, H., ITO, N., HACHISUKA, M., KOBAYASHI, S., FUJIMOTO, Y., HAGIWARA, K., MURATA, H., YODOGAWA, K., SHIMIZU, W., & ASAI, K. (2023). ENLARGED RIGHT ATRIUM PREDICTS PACEMAKER IMPLANTATION AFTER ATRIAL FIBRILLATION ABLATION IN PATIENTS WITH TACHYCARDIA-BRADYCARDIA SYNDROME. IJC HEART & VASCULATURE, 49, 101297. HTTPS://DOI.ORG/10.1016/J.IJCHA.2023.101297.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED: FROM 2011 TO 2020, 103 CONSECUTIVE PATIENTS DIAGNOSED WITH TACHYCARDIA-BRADYCARDIA SYNDROME (TBS) WERE RETROSPECTIVELY ENROLLED IN THE STUDY. AMONG THE 103 PATIENTS, 54 UNDERWENT PACEMAKER IMPLANTATIONS (PMIS) AND 49 CATHETER ABLATION (CA) OF ATRIAL FIBRILLATION. PMIS WERE PERFORMED IN 11 PATIENTS (PMI GROUP) AND THE REMAINING 38 DID NOT RECEIVE A PMI (NON-PMI GROUP). AMONG THE 49 PATIENTS, THE ABLATION WAS PERFORMED BY RADIOFREQUENCY CA IN 42 PATIENTS AND CRYOABLATION IN 7. ALL PATIENTS UNDERWENT A SUCCESSFUL CIRCUMFERENTIAL PV ISOLATION. ALL ANTIARRHYTHMIC DRUGS WERE DISCONTINUED FOR AT LEAST FIVE HALF-LIVES BEFORE THE ABLATION. THE ELECTROPHYSIOLOGICAL STUDY AND CA WERE PERFORMED IN A FASTING STATE UNDER CONSCIOUS SEDATION AFTER AN APPROPRIATE DOSE OF ANTICOAGULATION FOR AT LEAST ONE MONTH. ALL PATIENTS UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY OR MULTIDETECTOR COMPUTED TOMOGRAPHY WITH CONTRAST MEDIUM WITHIN ONE MONTH PRIOR TO THE CA TO EXCLUDE LEFT ATRIAL THROMBI. A TRANSSEPTAL PUNCTURE WAS PERFORMED USING AN RF NEEDLE INSERTED THROUGH A LONG NON-BOSTON SCIENTIFIC SHEATH. HEPARIN WAS INITIATED BEFORE THE TRANSSEPTAL PUNCTURE AND AN ACTIVATED CLOTTING TIME OF 300 TO 350 S WAS MAINTAINED WITH A CONTINUOUS ADMINISTRATION OF HEPARIN DURING CATHETER MANIPULATION AND THE ABLATION PROCEDURE IN THE LEFT ATRIUM (LA). AFTER TRANSSEPTAL ACCESS, CIRCULAR MAPPING CATHETERS AND AN IRRIGATED ABLATION CATHETER WERE INSERTED INTO THE LA. A NON-BOSTON SCIENTIFIC STEERABLE SHEATH WAS USED FOR THE ABLATION CATHETER IN ALL PROCEDURES. THE PROCEDURES WERE GUIDED WITH AN ELECTROANATOMICAL MAPPING SYSTEM OR ENSITE VELOCITY SYSTEM. IN PATIENTS WHO UNDERWENT CRYOBALLOON ABLATION, THE 28 MM CRYOBALLOON CATHETER WAS UTILIZED THROUGH THE STEERABLE SHEATH INTO THE LA WITH A 20-MM SMALL-DIAMETER CIRCULAR MAPPING CATHETER INSERTED IN THE CENTRAL LUMEN OF THE CRYOBALLOON AND USED AS A GUIDEWIRE. PROCEDURE-RELATED COMPLICATIONS OCCURRED IN TWO PATIENTS; ONE PATIENT HAD A STROKE, AND ANOTHER HAD PERICARDITIS WITH A SMALL PERICARDIAL EFFUSION, WHICH WAS SUCCESSFULLY MANAGED WITHOUT PERICARDIOCENTESIS. IN CONCLUSION, THE MAIN FINDINGS OF THE STUDY CAN BE SUMMARIZED AS FOLLOWS: (1) CA OF AF IN PATIENTS WITH TBS WHO DID NOT RECEIVE A PACEMAKER INCLUDED 77.6% OF THE SUBJECTS, (2) PATIENTS WHO UNDERWENT A PMI AFTER AF ABLATION HAD A SIGNIFICANTLY LARGER RIGHT ATRIUM, AND (3) THE AF FREE SURVIVAL RATE WAS SIGNIFICANTLY HIGHER IN THE PATIENT WHO DID NOT RECEIVE A PMI AFTER THE AF ABLATION THAN IN THOSE WHO RECEIVED A PMI AMONG THE PATIENTS WITH TBS. ARAI, T., IWASAKI, Y., HAYASHI, H., ITO, N., HACHISUKA, M., KOBAYASHI, S., FUJIMOTO, Y., HAGIWARA, K., MURATA, H., YODOGAWA, K., SHIMIZU, W., & ASAI, K. (2023). ENLARGED RIGHT ATRIUM PREDICTS PACEMAKER IMPLANTATION AFTER ATRIAL FIBRILLATION ABLATION IN PATIENTS WITH TACHYCARDIA-BRADYCARDIA SYNDROME. IJC HEART & VASCULATURE, 49, 101297. HTTPS://DOI.ORG/10.1016/J.IJCHA.2023.101297.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486303 NRG RF TRANSSEPTAL KIT CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other