BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 22436975 · Received July 8, 2025

    Report

    Report Number
    2124215-2025-44021
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    January 1, 2018
    Report Date
    July 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT HAS BEEN POPULATED AS 01/01/2018. THE EVENT DATE WAS NOT PROVIDED. PER THE ARTICLE THE PROCEDURES OCCURRED BETWEEN JANUARY 2018 AND AUGUST 2024. THE PATIENT SYMPTOMS OCCURRED POST OPERATIVELY, WITH PROCEDURE DATES AS EARLY AS (B)(6) 2018. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC, AS THE INFORMATION WAS PROVIDED VIA A LITERATURE REVIEW. AS THERE WAS NO INDICATION OF PRODUCT MALFUNCTION, AND THE COMPLICATIONS OCCURRED POST OPERATIVELY, THE DEVICE WAS DISPOSED OF, AND THE DETAILED DEVICE INFORMATION CANNOT BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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 THAT POST OPERATIVELY, 28 PATIENTS EXPERIENCED RECURRENT ARRHYTHMIA. PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS SINGLE CENTER STUDY AT UNIVERSITY HOSPITAL BASEL, SWITZERLAND, BETWEEN JANUARY 2018 AND AUGUST 2024, 220 PATIENTS WITH A HISTORY OF PERSISTENT ATRIAL FIBRILLATION (AF) UNDERWENT CATHETER ABLATION WITH TWO (2) DIFFERENT TECHNOLOGIES; PULSE FIELD ABLATION (PFA) AND CRYO ABLATION (CRYO). PFA AND CRYO PULMONARY VEIN ISOLATION (PVI) PROCEDURES WERE PERFORMED USING FARAWAVE AND POLARX CATHETERS RESPECTIVELY. ALL PROCEDURES WERE CONDUCTED UNDER SEDATION AND UNINTERRUPTED ANTICOAGULATION. 113 PATIENTS UNDERWENT PFA AND 107 PATIENTS WERE TREATED VIA CRYOABLATION. ALL PATIENTS RECEIVED TRANSESOPHAGEAL ECHOCARDIOGRAPHY THE DAY BEFORE THE PROCEDURE TO RULE OUT A LEFT ATRIAL THROMBUS. PREPROCEDURAL IMAGING OF THE LEFT ATRIUM, EITHER THROUGH COMPUTED TOMOGRAPHY OR MAGNETIC RESONANCE IMAGING, WAS PERFORMED IN EACH PARTICIPANT. PROCEDURES WERE PERFORMED UNDER SEDATION USING MIDAZOLAM, FENTANYL AND PROPOFOL. THE FEMORAL ACCESS WAS PLACED WITH ULTRASOUND GUIDANCE. FLUOROSCOPIC GUIDANCE OR, IN SELECTED CASES, INTRACARDIAC OR TRANSESOPHAGEAL ECHOCARDIOGRAPHIC GUIDANCE WAS USED FOR TRANSSEPTAL PUNCTURE. FOR THE PFA GROUP, AFTER ACHIEVING TRANSSEPTAL PUNCTURE, THE PULMONARY VEIN (PV) WAS CANNULATED USING A J-TIP GUIDEWIRE, AND THE FARAWAVE ABLATION CATHETER WAS POSITIONED IN THE LEFT ATRIUM. THE PVS WERE ISOLATED USING 4 PFA APPLICATIONS PER PV WITH A VOLTAGE OF 2 KV IN BOTH THE BASKET CONFIGURATION AND THE FLOWER CONFIGURATION. ADDITIONALLY, PATIENTS RECEIVED 2 PFA APPLICATIONS IN FLOWER CONFIGURATION AT THE RIGHT-SIDED CARINA. THE CATHETER WAS ROTATED BY 30 TO 40 DEGREES AFTER TWO CONSECUTIVE APPLICATIONS IN EACH CONFIGURATION TO ENSURE UNIFORM COVERAGE OF THE ENTIRE CIRCUMFERENCE. THE PROCEDURAL ENDPOINT WAS DEFINED AS PVI, ASSESSED DIRECTLY AT THE END OF PROCEDURE FOR ALL PV USING THE FARAWAVE CATHETER. FOR ENDPOINT CONFIRMATION, ENTRANCE AND, IF DEEMED NECESSARY, E.G. DUE TO RESIDUAL FAR-FIELD ATRIAL SIGNAL, EXIT BLOCK WAS TESTED VIA THE PFA CATHETER BY PACING WITH WITH 5 V AND A PULSE-WIDTH OF 1.0 MS MS AMONG ALL ELECTRODES OR VIA A 3D-ELECTROANATOMICAL MAPPING SYSTEM. FOR THE CRYO GROUP, THE POLARX ABLATION CATHETER WAS PLACED IN THE LEFT ATRIUM AND THE SHEATH AND CATHETER WERE ALIGNED TO OCCLUDE THE PV. THE FREEZING CYCLE LENGTH WAS 180 TO 240 S. FREEZING CYCLES WERE TERMINATED EARLY IF PHRENIC NERVE INJURY OCCURRED OR IF THE TEMPERATURES OF 70 DEGREES CELSIUS WERE REACHED. NO ADDITIONAL FREEZES WERE PERFORMED WITH ANY OF THE ABLATION SYSTEMS ONCE A PV WAS SUCCESSFULLY ISOLATED. PHRENIC NERVE INJURY (PNI) WAS MONITORED BY CONTINUOUSLY PACING THE RIGHT PHRENIC NERVE (PN) VIA THE RIGHT SUBCLAVIAN VEIN DURING THE FREEZING OF THE RIGHT PULMONARY VEINS, AND IF A DECREASE IN PN FUNCTION (CMAP REDUCTION GREATER THAN 30 PERCENT) WAS DETECTED, THE FREEZING PROCESS WAS IMMEDIATELY HALTED. THE PROCEDURAL ENDPOINT WAS DEFINED AS PVI, ASSESSED DIRECTLY AT THE END OF PROCEDURE FOR ALL PV. FOR ENDPOINT CONFIRMATION, ENTRANCE AND, IF DEEMED NECESSARY, E.G. DUE TO RESIDUAL FAR- FIELD ATRIAL SIGNAL, EXIT BLOCK WAS TESTED VIA THE SPIRAL MAPPING CATHETER BY PACING WITH 10 V AND A PULSE-WIDTH OF 1.0 MS AMONG ALL ELECTRODES. ACUTE PVI WAS ACHIEVED IN 100 PERCENT OF CASES. OVERALL, COMPLICATIONS OCCURRED IN 5 CASES. SPECIFICALLY, 3 COMPLICATIONS IN 2 PATIENTS WERE OBSERVED IN THE PFA GROUP, INCLUDING 2 CASES OF STROKE/TIA AND 1 CASE OF PERICARDIAL TAMPONADE, TREATED WITH DRAINAGE. ONE CASE OF STROKE OCCURRED 2 DAYS AFTER PVI AND RESULTED IN MILD ATAXIA AND REDUCED FINE MOTOR SKILLS OF THE LEFT HAND, BOTH OF WHICH PERSISTED AT DISCHARGE AND DURING 6-MONTHS FOLLOW-UP. THE OTHER CASE EXPERIENCED TRANSIENT DIPLOPIA FOR 6 H POST-PROCEDURE, WAS ADMITTED TO THE STROKE UNIT, AND DISCHARGED HOME WITHOUT ANY RESIDUAL SYMPTOMS. IN THE CRYO GROUP, A TOTAL OF 2 COMPLICATIONS WERE NOTED WITH 2 CASES OF PHRENIC NERVE PALSIES. ONE CASE OF PHRENIC NERVE PALSY PERSISTED AT DISCHARGE, WHILE THE OTHER CASE WAS ASYMPTOMATIC UPON DISCHARGE. BOTH PHRENIC NERVE PALSIES RECOVERED FULLY DURING FOLLOW-UP. AMONG 70 PATIENTS WITH RECURRENT ATRIAL ARRHYTHMIA, 28 OCCURRED IN THE PFA GROUP AND 42 IN THE CRYO GROUP. NO PATIENTS SUFFERED MAJOR COMPLICATIONS (BLEEDING REQUIRING THORACOTOMY OR TRANSFUSION, PERMANENT PHRENIC NERVE PARALYSIS, PACEMAKER DEVICE IMPLANTATION, ATRIO-ESOPHAGEAL FISTULATE REQUIRING SURGERY, DEATH) DURING OR AFTER THE ABLATION. THE DEVICES WERE DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICES PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. ISENEGGER, C., ARNET, R., JORDAN, F., KNECHT, S., KRISAI, P., VOLLMIN, G., BRUGGER, J., SPREEN, D., SCHAERLI, N., SUBIN, B., SCHAR, B., FORMENTI, N., MAHFOUD, F., STICHERLING, C., KUHNE, M., & BADERTSCHER, P. (2025). PULSED-FIELD ABLATION VERSUS CRYOBALLOON ABLATION IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION. IJC HEART & VASCULATURE, 59, 101684. HTTPS://DOI.ORG/10.1016/J.IJCHA.2025.101684.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391641 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other