BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 22935379 · Received September 2, 2025

    Report

    Report Number
    2124215-2025-61289
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    January 1, 2016
    Report Date
    September 1, 2025
    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

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC 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 THE PATIENT EXPERIENCED ATRIAL ARRHYTHMIA RECURRENCE. PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS MULTI-CENTER STUDY AT THE HOPITAL UNIVERSITAIRE PITIE-SALPETRIERE, FRANCE, BERN UNIVERSITY HOSPITAL, SWITZERLAND & UNIVERSITY HOSPITAL BASEL, SWITZERLAND, BETWEEN 2016 AND 2024, 109 PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (AF) UNDERWENT SUCCESSFUL PULMONARY VEIN ISOLATION (PVI) PROCEDURES USING PULSE FIELD ABLATION (PFA) OR THERMAL ABLATION (CRYOBALLOON OR RADIOFREQUENCY). PATIENTS WERE DIVIDED INTO 2 GROUPS; PFA (N=58) AND THERMAL ABLATION (N=51). CATHETER ABLATION PROCEDURES WERE PERFORMED WITH THE PATIENT UNDER GENERAL ANESTHESIA OR DEEP SEDATION ACCORDING TO EACH CENTER PROTOCOL. TRANSEPTAL PUNCTURE WAS PERFORMED BY USING FLUOROSCOPY OR TRANSESOPHAGEAL ECHOCARDIOGRAPHY. FOR PFA, THE FARAPULSE PULSED FIELD ABLATION SYSTEM WAS USED. LN BRIEF, 4 APPLICATIONS PER PULMONARY VEIN (PV) IN BOTH BASKET AND FLOWER CONFIGURATIONS WERE PERFORMED WITH AN APPROXIMATE 36-DEGREE ROTATION AFTER 2 APPLICATIONS, FOR A MINIMUM OF 8 APPLICATIONS PER PV. ADDITIONAL PFA APPLICATIONS ON THE PVS WERE ADMINISTERED AS DEEMED NECESSARY BY THE OPERATOR. EXTRA-PV ABLATION WAS PERFORMED ON THE LEFT ATRIAL POSTERIOR WALL AND/OR MITRAL ISTHMUS. PVI WAS OBTAINED IN 107 (98%) PATIENTS. THERE WERE NO PROCEDURE RELATED DEATHS. THERE WERE 2 CARDIAC TAMPONADES IN THE PFA GROUP (WHICH RESOLVED WITH PERCUTANEOUS DRAINAGE). OVERALL, 51 (47%) PATIENTS EXPERIENCED SUSTAINED ATRIAL ARRHYTHMIA (AA) RECURRENCE. 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. GRIBISSA, S., KUEFFER, T., KNECHT, S., WAINTRAUB, X., BADENCO, N., CHARRON, P., PINON, P., KING, R., GANDJBAKHCH, E., DUTHOIT, G., STICHERLING, C., REICHLIN, T., ET LAREDO, M. (2025). PULSED-FIELD VS THERMAL CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH HYPERTROPHIC CARDIOMYOPATHY. JACC: CLINICAL ELECTROPHYSIOLOGY, 11(6), 1205-1215. HTTPS://DOI.ORG/10.1016/J.JACEP.2025.01.009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260898 FARAWAVE PULSED FIELD ABLATION CATHETER CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other