BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE

    MDR report key: 23518175 · Received November 10, 2025

    Report

    Report Number
    2124215-2025-73934
    Event Type
    Death
    Date Received
    November 10, 2025
    Date of Event
    March 1, 2021
    Report Date
    January 13, 2026
    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

    CHAUMONT, CORENTIN ET AL. COUNTRYWIDE INTRODUCTION OF PULSED FIELD ABLATION FOR THE TREATMENT OF ATRIAL FIBRILLATION: ACUTE RESULTS FROM THE FRANCE-PFA REGISTRY. HEART RHYTHM O2, VOLUME 6, JULY 2025, ISSUE 7, 911 - 919. 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 AND IT WAS NOT AVAILABLE BECAUSE THE EVENT WAS REPORTED VIA LITERATURE ARTICLE. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION ADDED PATIENT CODE E0611: HEART FAILURE/CONGESTIVE HEART FAILURE D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. CHAUMONT, CORENTIN ET AL. COUNTRYWIDE INTRODUCTION OF PULSED FIELD ABLATION FOR THE TREATMENT OF ATRIAL FIBRILLATION: ACUTE RESULTS FROM THE FRANCE-PFA REGISTRY. HEART RHYTHM O2, VOLUME 6, JULY 2025, ISSUE 7, 911 - 919. 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 AND IT WAS NOT AVAILABLE BECAUSE THE EVENT WAS REPORTED VIA LITERATURE ARTICLE. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT A PATIENT DEATH OCCURRED. REGISTRY STUDY FRANCE PFA ((B)(6)) INCLUDED ALL PATIENTS WHICH HAD UNDERGONE A FIRST ATRIAL FIBRILLATION (AF) PULSE FIELD ABLATION PROCEDURE (PFA) ACROSS THIRTY THREE (33) HEALTH CARE FACILITIES IN FRANCE BETWEEN MARCH 2021 AND FEBRUARY 2024. THIS STUDY AIMED TO PROVIDE EXHAUSTIVE AND PROSPECTIVE PATIENT-LEVEL DATA ON A NEW ABLATION MODALITY, PFA. PROCEDURE SUMMARY FIVE THOUSAND TWO HUNDRED AND TWENTY THREE (5223) PATIENTS UNDERWENT AN AF PFA PROCEDURE USING A FARAWAVE CATHETER AND ACUTE PULMONARY VEIN ISOLATION (PVI) WAS ACHIEVED IN FIVE THOUSAND TWO HUNDRED AND ELEVEN (5211) PATIENTS. PROCEDURES WERE PERFORMED WITH UNINTERRUPTED ORAL ANTICOAGULATION. ALL PROCEDURES WERE CONDUCTED UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION, LARYNGEAL MASK, OR DEEP SEDATION (SPONTANEOUS VENTILATION). PVI PROTOCOL CONSISTED OF PAIRS OF ENERGY APPLICATIONS CONSISTING OF TWO (2) APPLICATIONS WITH THE FARAWAVE CATHETER IN THE BASKET CONFIGURATION, FOLLOWED BY A SLIGHT ROTATION OF THE CATHETER AND TWO (2) ADDITIONAL APPLICATIONS. THIS ABLATION SEQUENCE WAS REPEATED WITH THE FARAWAVE CATHETER IN THE FLOWER CONFIGURATION AND APPLIED AT EACH PULMONARY VEIN (PV) WITH A TOTAL OF THIRTY TWO (32) APPLICATIONS. ADDITIONAL PFA APPLICATIONS AT THE PULMONARY VEIN ANTRA, LEFT ATRIUM ROOF, POSTERIOR LEFT ATRIUM WALL, MITRAL ISTHMUS (MI), SUPERIOR VENA CAVA (SVC), AND CAVOTRICUSPID ISTHMUS (CTI) WERE LEFT TO THE DISCRETION OF THE PHYSICIAN. PVI WAS CONFIRMED BY THE ABSENCE OF DISCRETE PV OR ATRIAL POTENTIALS AT THE PV ANTRA, USING THE FARAWAVE CATHETER. PROCEDURAL COMPLICATIONS A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TERMINAL HEART FAILURE. THE PATIENT UNDERWENT AN AF PFA PROCEDURE USING A FARAWAVE CATHETER. ONE (1) DAY POST INDEX PROCEDURE THE PATIENT DIED DUE TO REFRACTORY HEART FAILURE. PATIENT IS DECEASED WITH A CAUSE OF DEATH OF REFRACTORY HEART FAILURE.

    Description of Event or Problem · 0

    REFERENCE LITERATURE [COUNTRYWIDE INTRODUCTION OF PULSED FIELD ABLATION FOR THE TREATMENT OF ATRIAL FIBRILLATION: ACUTE RESULTS FROM THE FRANCE-PFA REGISTRY] INCLUDED WITH THIS REPORT FOR FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES. IT WAS REPORTED VIA LITERATURE THAT HEART FAILURE AND DEATH OCCURRED. REGISTRY STUDY FRANCE PFA (NCT06497933) INCLUDED ALL PATIENTS WHICH HAD UNDERGONE A FIRST ATRIAL FIBRILLATION (AF) PULSE FIELD ABLATION PROCEDURE (PFA) ACROSS THIRTY-THREE (33) HEALTH CARE FACILITIES IN FRANCE BETWEEN MARCH 2021 AND FEBRUARY 2024. THIS STUDY AIMED TO PROVIDE EXHAUSTIVE AND PROSPECTIVE PATIENT-LEVEL DATA ON A NEW ABLATION MODALITY, PFA. PROCEDURE SUMMARY: FIVE THOUSAND TWO HUNDRED AND TWENTY-THREE (5223) PATIENTS UNDERWENT AN AF PFA PROCEDURE USING A FARAWAVE CATHETER AND ACUTE PULMONARY VEIN ISOLATION (PVI) WAS ACHIEVED IN FIVE THOUSAND TWO HUNDRED AND ELEVEN (5211) PATIENTS. PROCEDURES WERE PERFORMED WITH UNINTERRUPTED ORAL ANTICOAGULATION. ALL PROCEDURES WERE CONDUCTED UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION, LARYNGEAL MASK, OR DEEP SEDATION (SPONTANEOUS VENTILATION). PVI PROTOCOL CONSISTED OF PAIRS OF ENERGY APPLICATIONS CONSISTING OF TWO (2) APPLICATIONS WITH THE FARAWAVE CATHETER IN THE BASKET CONFIGURATION, FOLLOWED BY A SLIGHT ROTATION OF THE CATHETER AND TWO (2) ADDITIONAL APPLICATIONS. THIS ABLATION SEQUENCE WAS REPEATED WITH THE FARAWAVE CATHETER IN THE FLOWER CONFIGURATION AND APPLIED AT EACH PULMONARY VEIN (PV) WITH A TOTAL OF THIRTY-TWO (32) APPLICATIONS. ADDITIONAL PFA APPLICATIONS AT THE PULMONARY VEIN ANTRA, LEFT ATRIUM ROOF, POSTERIOR LEFT ATRIUM WALL, MITRAL ISTHMUS (MI), SUPERIOR VENA CAVA (SVC), AND CAVOTRICUSPID ISTHMUS (CTI) WERE LEFT TO THE DISCRETION OF THE PHYSICIAN. PVI WAS CONFIRMED BY THE ABSENCE OF DISCRETE PV OR ATRIAL POTENTIALS AT THE PV ANTRA, USING THE FARAWAVE CATHETER. PROCEDURAL COMPLICATIONS: A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TERMINAL HEART FAILURE. THE PATIENT UNDERWENT AN AF PFA PROCEDURE USING A FARAWAVE CATHETER. ONE DAY POST INDEX PROCEDURE THE PATIENT DIED DUE TO REFRACTORY HEART FAILURE. PATIENT STATUS: PATIENT IS DECEASED WITH A CAUSE OF DEATH OF REFRACTORY HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580783 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death