BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 19756306 · Received July 16, 2024

    Report

    Report Number
    2124215-2024-43693
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    July 1, 2023
    Report Date
    July 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT REQUIRED A REDO PROCEDURE DUE TO ATRIAL FIBRILLATION RECURRENCE. PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS SINGLE-CENTER STUDY AT THE CLINIQUE PASTEUR, TOULOUSE, FRANCE, 45 PATIENTS TREATED FOR PERSISTENT SYMPTOMATIC ATRIAL FIBRILLATION (AF) USING PULSED FIELD ABLATION BETWEEN NOVEMBER 2021 AND SEPTEMBER 2022 WERE INCLUDED. PRE-PROCEDURAL INVESTIGATIONS INCLUDED TRANSESOPHAGEAL ECHOCARDIOGRAPHY OR CARDIAC COMPUTED TOMOGRAPHY (CT) SCAN. ALL PROCEDURES WERE PERFORMED USING GENERAL ANESTHESIA EXECUTED BY A SEDATION SPECIALIST. ACCESS TO THE LEFT ATRIUM WAS PERFORMED BY STANDARD TRANSSEPTAL SINGLE PUNCTURE UNDER FLUOROSCOPIC CONTROL. A DECAPOLAR CATHETER WAS POSITIONED IN THE CORONARY SINUS. AFTER THE TRANSSEPTAL PUNCTURE, A 13-F STEERABLE FARADRIVE SHEATH WAS INSERTED, AND A 12-F OVER-THE-WIRE FARAWAVE CATHETER (31 OR 35 MM) WAS ADVANCED. DURING ABLATION, THE FIRST STEP WAS PULMONARY VEIN ISOLATION (PVI). BASELINE ELECTRICAL POTENTIALS WERE RECORDED FROM PULMONARY VEINS, THEN AT LEAST 4 PAIRS OF APPLICATIONS WERE PERFORMED PER VEIN (2 PAIRS IN BASKET POSITION, 2 PAIRS IN FLOWER) WITH ROTATION BETWEEN EACH PAIR. PVI WAS CONFIRMED BY ENTRANCE BLOCK AND EXIT BLOCK. THE SECOND STEP WAS POSTERIOR WALL (PW) ISOLATION, WHICH WAS PERFORMED BY APPLICATIONS IN FLOWER POSITION, FROM THE LEFT PULMONARY VEINS TO THE RIGHT PULMONARY VEINS. THE THIRD STEP WAS MITHRAL ISTHMUS (MI) ABLATION. MI ABLATION WAS PERFORMED THROUGH APPLICATIONS IN FLOWER POSITION, EXTENDING FROM THE MITRAL ANNULUS TO THE LEFT INFERIOR PULMONARY VEIN, UNTIL MITRAL BLOCK WAS OBTAINED. IF AF EVOLVED INTO A RIGHT ATRIAL FLUTTER, A CAVOTRICUSPID ISTHMUS (CTI) LINE WAS PERFORMED WITH AN 8-MM RF BLAZER II CATHETER UNTIL CTI BIDIRECTIONAL CONDUCTION BLOCK WAS ASSESSED. OF THE 45 PATIENTS THAT RECEIVED PFA TREATMENT, 4 PATIENTS UNDERWENT A REDO PROCEDURE DUE TO AF OR ATYPICAL FLUTTER RECURRENCE. IN ALL PATIENTS, ALL PVS, MIS, PWS & CTIS (100%) WERE CONFIRMED TO BE ISOLATED AT THE END OF ABLATION. TWO PATIENTS (4.4%) PRESENTED RIGHT ATRIAL FLUTTER DURING THE INDEX PROCEDURE, WHICH WAS TREATED WITH RF. NO PATIENTS SUFFERED MAJOR COMPLICATIONS (BLEEDING REQUIRING THORACOTOMY OR TRANSFUSION, PERMANENT PHRENIC NERVE PARALYSIS, PACEMAKER DEVICE IMPLANTATION, STROKE/TRANSIENT ISCHEMIC ATTACK, ATRIO-ESOPHAGEAL FISTULATE REQUIRING SURGERY, DEATH) DURING OR AFTER THE ABLATION. COMPLICATIONS OCCURRED IN 3 PATIENTS (6.6%) : 2 CASES OF CORONARY SPASM OF THE CIRCUMFLEX ARTERY THAT OCCURRED DURING MI ABLATION, AND 1 CASE OF AIR EMBOLISM. ONE OF THE CASES OF CORONARY SPASM OCCURRED IN A PATIENT THAT MANIFESTED WITH TRANSIENT ST-SEGMENT ELEVATION IN INFERIOR LEADS DURING ONE OF THE LAST MI APPLICATIONS. DURING ST-SEGMENT ELEVATION, THERE PATIENT EXPERIENCED HYPOTENSION, WHICH WAS ACUTELY TREATED WITH SERUM INFUSION. NITRATES WERE ADMINISTERED (2 MG INTRAVENOUS NITROGLYCERIN), AFTER WHICH THE ST-SEGMENT ELEVATION COMPLETELY RESOLVED WITHIN 2 MINUTES. THE SECOND CASE OF CORONARY SPASM TOOK PLACE DURING THE APPLICATIONS IN THE MI, IN THIS CASE AT THE FOURTH APPLICATION. THE PATIENT PRESENTED WITH ST SEGMENT DEPRESSIONS ASSOCIATED WITH QRS WIDENING (FROM 100 TO 135 MS) AND HYPOTENSION (MEAN BLOOD PRESSURE OF 50 MM HG). IMMEDIATE CORONARY ANGIOGRAPHY SHOWED 3-VESSEL DISEASE WITH CIRCUMFLEX ARTERY SPASM ON A PREEXISTING LESION. THE SPASM QUICKLY REGRESSED AFTER ADMINISTRATION OF 1 MG INTRACORONARY NITROGLYCERIN AND THE ELECTROCARDIOGRAPHY NORMALIZED. A THIRD CASE OF TRANSIENT ST-SEGMENT DEPRESSION IN ANTERIOR LEADS APPEARED DURING MINUTE 8 OF THE WAITING PERIOD, AFTER ALL APPLICATIONS WERE COMPLETED. HYPOTENSION WITHOUT RHYTHM ALTERATIONS WAS ALSO OBSERVED IN THIS CASE. CORONAROGRAPHY DURING ST SEGMENT DEPRESSION FOUND NO SPASM OR CORONARY LESION, THUS ADVOCATING FOR AIR EMBOLISM. DAVONG, B., ADELINO, R., DELASNERIE, H., ALBENQUE, J.-P., COMBES, N., CARDIN, C., VOGLIMACCI-STEPHANOPOLI, Q., COMBES, S., & BOVEDA, S. (2023). PULSED-FIELD ABLATION ON MITRAL ISTHMUS IN PERSISTENT ATRIAL FIBRILLATION. JACC: CLINICAL ELECTROPHYSIOLOGY, 9(7), 1070-1081. HTTPS://DOI.ORG/10.1016/J.JACEP.2023.03.021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748997 FARAWAVE PULSED FIELD ABLATION CATHETER CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention