BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 24548035 · Received March 9, 2026

    Report

    Report Number
    2124215-2026-12928
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    July 9, 2025
    Report Date
    April 23, 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

    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. D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED THAT PHRENIC NERVE INJURY OCCURRED. THIS STUDY AIMED TO EVALUATE THE INCIDENCE AND CHARACTERISTICS OF PHRENIC NERVE INJURY (PNI) DURING PULSE FIELD ABLATION (PULSE FIELD ABLATION (PFA) USING SEQUENTIAL COMPOUND MOTOR ACTION POTENTIAL (CMAP) MONITORING AND ASSESS DIAPHRAGMATIC FUNCTION AT DISCHARGE. THIS PROSPECTIVE STUDY INCLUDED 64 CONSECUTIVE PATIENTS UNDERGOING PFA FOR AF. RIGHT PHRENIC NERVE FUNCTION WAS MONITORED USING CMAP DURING ABLATION. A BASELINE AMPLITUDE WAS MEASURED BEFORE RIGHT PULMONARY VEIN ABLATION AND SUBSEQUENTLY MONITORED SEQUENTIALLY THROUGHOUT THE PROCEDURE. IN CASE OF INTRA-PROCEDURAL PNI, ALL PATIENTS UNDERWENT A CHEST X-RAY, AND THE LAST 25 ALSO HAD A FLUOROSCOPIC LOOP THE FOLLOWING DAY. PNI OCCURRED IN 26 PATIENTS. INCOMPLETE RECOVERY WAS OBSERVED IN 12 THE END OF THE PROCEDURE. CHEST X-RAYS WERE NORMAL IN ALL CASES. AMONG THE LAST 25 PATIENTS, 12 EXPERIENCED INTRA-PROCEDURAL PNI AND UNDERWENT FLUOROSCOPIC ASSESSMENT AT DISCHARGE, OF WHOM 6 PATIENTS HAD PERSISTENT INCOMPLETE PNI. THE OVERALL INCIDENCE OF PNI AT DISCHARGE WAS 6 OUT OF 25. FOLLOW-UP FLUOROSCOPY CONFIRMED RECOVERY IN 4 OF 5 PATIENTS REASSESSED, WHILE 1 SHOWED PERSISTENT DYSFUNCTION AT 3 MONTHS. NO DEVICE IS EXPECTED TO RETURN AS THIS IS FROM A LITERATURE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605888 FARAWAVE NO MATCH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention