BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 16043469 · Received December 23, 2022

    Report

    Report Number
    3019751610-2022-00078
    Event Type
    Injury
    Date Received
    December 23, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 23, 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 THAT REASONABLY SUGGESTS A 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 PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Description of Event or Problem · 0

    DURING A LITERATURE REVIEW, IT WAS NOTED THAT CARDIAC TAMPONADE, PERICARDIAL EFFUSION, CORONARY ARTERY SPASM, CEREBROVASCULAR EVENT, HEART FAILURE WORSENING, HEMATOMA, PERICARDITIS, PHRENIC NERVE PALSY, THROMBOSIS DURING CRYOBALLOON ABLATION PROCEDURE. "MULTIPOLAR CATHETERS WITH INTERNAL CARDIOVERSION (BEEAT, JAPAN-LIFE-LINE, TOKYO, JAPAN) WERE PLACED IN THE CORONARY SINUS THROUGH THE INTERNAL JUGULAR VEIN, AND A DEFLECTABLE MULTIPOLAR CATHETER WAS PLACED IN THE RIGHT VENTRICLE OR RIGHT ATRIUM THROUGH THE RIGHT FEMORAL VEIN. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN RF NEEDLE (BAYLIS MEDICAL, MONTREAL, QC, CANADA) UNDER INTRACARDIAC ECHOCARDIOGRAPHIC GUIDANCE, AND 1 OR 2 SHEATHS WERE INTRODUCED INTO THE LA. THREE-DIMENSIONAL (3D) VOLTAGE OR COMPLEX FRACTIONATED ATRIAL ELECTROGRAM (CFAE) MAPS OF THE LA AND PVS BEFORE PVI WERE OBTAINED WITH AN ENSITE PRECISION MAPPING SYSTEM (ABBOTT, ST. PAUL, MN, USA) IN THE CRYOBALLOON GROUP OR THE CARTO3 SYSTEM (VERSION 6 OR 7; BIOSENSE WEBSTER INC., IRVINE, CA, USA) IN THE CFRF GROUP. THE PREPROCEDURAL CT IMAGE OF THE LA WAS INTEGRATED WITH THE 3D ELECTROANATOMICAL MAP. ESOPHAGEAL LUMINAL TEMPERATURE WAS MONITORED USING A TEMPERATURE-SENSING PROBE (ESOPHASTAR, JAPAN-LIFE-LINE, CRYOBALLOON GROUP; SENSITHERM MULTI, ABBOTT, CFRF GROUP). AS PER TABLE 2. PROCEDURE OUTCOMES AND ADVERSE EVENTS, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: BRADYCARDIA (1); CARDIAC TAMPONADE (3); PERICARDIAL EFFUSION (2), CORONARY ARTERY SPASM (3); CEREBROVASCULAR EVENT (1); GASTROINTESTINAL BLEEDING (1); HEART FAILURE WORSENING (4); HEMATOMA (8); PERICARDITIS (2); PHRENIC NERVE PALSY (4); TRANSIENT AT-DISCHARGE (2); THROMBOSIS (1)." THERE IS NO EVIDENCE THAT REASONABLY SUGGESTS A 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 PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. [1] DOI: 10.1253/CIRCJ.CJ-21-0608

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653224 NRG TRANSSEPTAL NEEDLE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other