BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARX

    MDR report key: 23153698 · Received September 26, 2025

    Report

    Report Number
    2124215-2025-66371
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 VIA LITERATURE THAT ONE PATIENT EXPERIENCED TRANSIENT ST SEGMENT ELEVATION, AND ONE PATIENT EXPERIENCED ATRIOVENTRICULAR BLOCK. ADDITIONALLY, THE CATHETER WAS USED OFF LABEL TO TREAT PERSISTENT (PAF) AND LONGSTANDING PAF. ONE YEAR POST OPERATIVELY SEVERAL PATIENTS EXPERIENCED RECURRENT ARRHYTHMIAS. IN THIS MULTI CENTER STUDY AT SIX DIFFERENT CENTERS: HEART RHYTHM MANAGEMENT CENTRE, BRUSSELS, BELGIUM; HEART RHYTHM DEPARTMENT, CLINIQUE PASTEUR, TOULOUSE, FRANCE; ARRHYTHMOLOGY UNIT, ISOLA TIBERINA GEMELLI ISOLA, ROME, ITALY; FIRST DEPARTMENT OF CARDIOLOGY, NATIONAL AND KAPODISTRIAN UNIVERSITY, HIPPOKRATION GENERAL HOSPITAL, ATHENS, GREECE; TEXAS CARDIAC ARRHYTHMIA INSTITUTE, ST DAVIDS MEDICAL CENTER, AUSTIN, TEXAS; AND DEPARTMENT OF CARDIOVASCULAR DISEASES, UNIVERSITY HOSPITAL CENTRE ZAGREB, ZAGREB, CROATIA; BETWEEN JANUARY 2017 AND FEBRUARY 2024, 983 PATIENTS, WITH A HISTORY OF SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION (AF), PERSISTENT (PAF) & LONGSTANDING PAF UNDERWENT CATHETER ABLATION WITH 3 DIFFERENT TECHNOLOGIES; PULSE FIELD ABLATION (PFA) CRYO ABLATION (CRYO) AND RADIOFREQUENCY ABLATION (RF). PFA AND CRYO PROCEDURES WERE PERFORMED USING FARAPULSE SYSTEM AND POLARX RESPECTIVELY. ALL PATIENTS UNDERWENT PULMONARY VEIN ISOLATION (PVI); ADDITIONAL ABLATION TARGETS WERE LEFT TO EACH OPERATORS PREFERENCE. ALL PROCEDURES WERE CONDUCTED UNDER GENERAL ANESTHESIA AND UNINTERRUPTED ORAL ANTICOAGULATION. ANTIARRHYTHMIC DRUG THERAPY, EXCEPT AMIODARONE, WAS DISCONTINUED AT LEAST 5 HALF LIVES BEFORE ABLATION. HEPARIN WAS ADMINISTERED BEFORE TRANSSEPTAL ACCESS AND DURING THE PROCEDURE, WHEN NEEDED, TO MAINTAIN THE ACTIVATED CLOTTING TIME BETWEEN 300 AND 350 SECONDS. ALL PATIENTS UNDERWENT PVI; ADDITIONAL ABLATION TARGETS WERE LEFT TO EACH OPERATORS PREFERENCE. FOR THE PFA GROUP, TWO ULTRASOUND GUIDED RIGHT GROIN ACCESSES WERE USED TO ACHIEVE TRANSSEPTAL ACCESS VIA AN 8.5 F SL0 FIXED SHEATH AND ADVANCE A 10 POLE CATHETER INTO THE CORONARY SINUS (CS) OR THE RIGHT VENTRICLE TO BE USED FOR PACING IN CASE OF PFA RELATED BRADYCARDIA. ONCE TRANSSEPTAL ACCESS WAS ACHIEVED, THE 8.5 F SL0 FIXED SHEATH WAS EXCHANGED WITH THE FARADRIVE SHEATH AND THE FARAWAVE CATHETER WAS USED TO ACHIEVE PULMONARY VEIN ISOLATION (PVI). PVI WAS PERFORMED WITH AT LEAST 4 PAIRS OF PFA APPLICATIONS (2 PAIRS IN BASKET AND 2 PAIRS IN FLOWER CONFIGURATION, EACH PAIR AT 36 DEGREES ROTATION FROM THE OTHER) PER VEIN. POSTERIOR WALL ISOLATION (PWI) WAS PERFORMED WITH THE ABLATION CATHETER IN THE FLOWER POSE AND BY CREATING 2 LINES OF ABLATION, EACH CONNECTING LEFT TO RIGHT SUPERIOR (I LINE) AND LEFT TO RIGHT INFERIOR (II LINE) VEINS. AT LEAST 2 APPLICATIONS PER POSITION WERE DELIVERED, WITH ADJACENT POSITIONS OVERLAPPING APPROXIMATELY 50 PERCENT. MITRAL ISTHMUS ABLATION WAS PERFORMED ANATOMICALLY UNDER FLUOROSCOPY GUIDANCE. APPLICATIONS WERE DELIVERED WITH THE CATHETER DEPLOYED INTO A FLOWER CONFIGURATION EXTENDING FROM THE LEFT INFERIOR PULMONARY VEIN (PV) TO THE MITRAL ANNULUS. AT LEAST 4 APPLICATIONS PER POSITION WERE DELIVERED WITH AN OVERLAP OF AT LEAST 50 PERCENT AND UNTIL BLOCK WAS ACHIEVED. MITRAL ISTHMUS BLOCK WAS CONFIRMED IF PACING FROM THE FLOWER POSITIONED AT THE OSTIUM OF THE LEFT ATRIAL APPENDAGE LED TO PROXIMAL TO DISTAL ACTIVATION ON THE DECAPOLAR CATHETER WITHIN THE CORONARY SINUS. CAVO TRICUSPID ISTHMUS ABLATION WAS PERFORMED WITH A FOCAL 4 MM OR 8 MM NONIRRIGATED CATHETER. THE FOLLOWING COMPLICATIONS WERE REPORTED: 1 CASE OF GROIN HEMATOMA THAT WAS TREATED CONSERVATIVELY, 1 CASE OF CORONARY ARTERY SPASM WITH TRANSIENT ST SEGMENT ELEVATION THAT PROMPTLY RESOLVED WITH INTRAVENOUS ADMINISTRATION OF NITRATE AND 1 CASE OF TRANSIENT ATRIOVENTRICULAR BLOCK IN A PATIENT WHO RECEIVED PVI, PWI, AND MITRAL ISTHMUS ABLATION FOLLOWED BY ELECTRICAL CARDIOVERSION. ADDITIONALLY, THERE WAS 1 CASE INVOLVING A PATIENT WITH A KNOWN HISTORY OF SYNCOPE, AND CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING DURING HOSPITAL STAY SHOWED INTERMITTENT HIGH DEGREE ATRIOVENTRICULAR BLOCK. THIS ADVERSE EVENT (PACEMAKER IMPLANTATION) WAS ADJUDICATED NEITHER PROCEDURE NOR TECHNOLOGY RELATED. FOR THE CRYO GROUP, TWO ULTRASOUND GUIDED RIGHT GROIN ACCESSES WERE USED TO ACHIEVE TRANSSEPTAL ACCESS VIA AN 8.5 F SL0 FIXED SHEATH AND ADVANCE A 10 POLE CATHETER INTO THE CS OR THE SUPERIOR VENA CAVA DURING RIGHT PV ABLATION IN ORDER TO MONITOR DIAPHRAGMATIC CAPTURE VIA PACING OF THE IPSILATERAL PHRENIC NERVE (1000 MS CYCLE, 20 MA OUTPUT). AFTER TRANSSEPTAL ACCESS WAS ACHIEVED, THE SL0 SHEATH WAS EXCHANGED WITH A DEDICATED STEERABLE SHEATH THAT WAS USED TO ADVANCE THE CRYO BALLOON DEVICE INTO THE LEFT ATRIUM. PV OCCLUSION WAS DOCUMENTED BY INJECTION OF CONTRAST MATERIAL THROUGH THE DISTAL CRYO BALLOON LUMEN. FREEZE DURATION WAS SET AT 240 SECONDS; ALTERNATIVELY, A 180 SECOND FREEZE WAS ADOPTED IF TIME TO ISOLATION WAS ACHIEVED WITHIN 60 SECONDS WITH A TEMPERATURE BELOW MINUS 40 DEGREES CELSIUS. IN CASE OF A COMMON PV OSTIUM, A SEGMENTAL SUPERIOR AND INFERIOR FULL APPLICATION SET WAS DELIVERED. PWI WAS PERFORMED ANATOMICALLY UNDER FLUOROSCOPY GUIDANCE. THE INNER LUMEN CIRCULAR MAPPING CATHETER WAS USED AS AN ANCHORING DEVICE WITHIN THE SUPERIOR OR INFERIOR PVS TO STABILIZE THE BALLOON ON THE POSTERIOR WALL AND TO TARGET IT IN A SEGMENTAL FASHION. EACH APPLICATION LASTED 120 TO 180 SECONDS. CAVOTRICUSPID ISTHMUS ABLATION WAS PERFORMED WITH A FOCAL 4 MM OR 8 MM NONIRRIGATED CATHETER. THE FOLLOWING COMPLICATIONS WERE REPORTED: 11 CASES OF PHRENIC NERVE INJURY, 1 CASE OF FISTULA AND 1 CASE OF GROIN HEMATOMA. THE 1 YEAR ATRIAL TACHYARRHYTHMIA FREEDOM IN THE PROPENSITY SCORE MATCHED POPULATION WAS 77.2 PERCENT WITH PFA, 80.8 PERCENT WITH CBA, AND 74.9 PERCENT WITH RFA. THE DEVICES WERE DISPOSED BY THE FACILITIES AND WILL NOT BE RETURNED AS THE DEVICES PERFORMED AS EXPECTED DURING THE PROCEDURES AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. NAKASONE, K., DELLA ROCCA, D. G., MAGNOCAVALLO, M., BETANCUR, A., VETTA, G., PANNONE, L., SORGENTE, A., AUDIAT, C., RODRIGUEZ, J., DOUNDOULAKIS, I., NEKIC, A., VELAGIC, V., POLSELLI, M., MOHANTY, S., MARCON, L., SIEIRA, J., STROKER, E., BALA, G., BIANCHI, S., CHIERCHIA, G.B. (2025A). PULSED FIELD ABLATION IN THE ELDERLY BY A PENTASPLINE MULTIELECTRODE CATHETER: SAFETY, EFFICACY, AND COMPARISON WITH CRYOBALLOON AND RADIOFREQUENCY DEVICES. HEART RHYTHM, 22(7). HTTPS://DOI.ORG/10.1016/J.HRTHM.2025.01.025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282213 POLARX CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BOSTON SCIENTIFIC DE COSTA RICA S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other