BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER

    MDR report key: 21437097 · Received February 21, 2025

    Report

    Report Number
    2124215-2025-10594
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    September 30, 2023
    Report Date
    February 21, 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

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC AS EVENT WAS REPORTED THROUGH AN ARTICLE OF INTEREST. 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 THE PATIENT EXPERIENCED A PERICARDIAL TAMPONADE AND REQUIRED A PERCUTANEOUS PERICARDIAL DRAINAGE. PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS SINGLE-CENTER STUDY AT UNIVERSITY HOSPITAL, BERN, SWITZERLAND; BETWEEN JANUARY 2019 AND FEBRUARY 2022, 200 PATIENTS WITH A HISTORY OF SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT CATHETER ABLATION WITH 3 DIFFERENT TECHNOLOGIES; PULSE FIELD ABLATION (PFA) CRYO ABLATION (CRYO) AND RADIO FREQUENCY ABLATION (RFA). PFA PROCEDURES WERE PERFORMED USING FARAPULSE SYSTEM. CRYO AND RFA WERE PERFORMED USING A COMPETITOR'S SYSTEM. ALL PROCEDURES WERE CONDUCTED UNDER DEEP CONSCIOUS SEDATION. FOR THE PFA GROUP, AFTER SUCCESSFUL LEFT ATRIUM (LA) ACCESS, THE STANDARD TRANSSEPTAL SHEATH WAS REPLACED BY THE 13-F STEERABLE FARADRIVE SHEATH. NEXT, THE FARAWAVE CATHETER WAS INTRODUCED INTO THE LA. A STRAIGHT-TIP 0.035 INCH WIRE OR A 0.035 INCH ROSEN-TIP J-WIRE WAS USED TO CANNULATE THE PULMONARY VEINS (PV). PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED WITH FOUR APPLICATIONS IN BASKET AND FOUR APPLICATIONS IN FLOWER CONFIGURATION PER PV AS PREVIOUSLY DESCRIBED TO COMPLETE THE STANDARD 32-APPLICATIONS LESION-SET. A TOTAL OF 200 PATIENTS WERE ENROLLED: 40 CONSECUTIVE PATIENTS WITH PFA PVI BETWEEN MAY 2021 AND FEBRUARY 2022, 80 PATIENTS WITH CBA PVI AND 80 WITH RFA PVI BETWEEN JANUARY 2019 AND MARCH 2021IN THE PFA GROUP, 2/40 PATIENTS (5.0%) SUFFERED FROM PERICARDIAL TAMPONADE AND REQUIRED A PERCUTANEOUS PERICARDIAL DRAINAGE. IN BOTH CASES, PERFORATION OF THE DIAGNOSTIC CATHETER PLACED FOR BACKUP PACING IN THE RIGHT VENTRICLE WAS ASSUMED CAUSATIVE (AND CONFIRMED DURING CARDIAC SURGERY IN THE SECOND PATIENT). AFTER THE SECOND TAMPONADE, THE WORKFLOW WAS CHANGED AND ADMINISTERED 0.5 MG ATROPINE BEFORE PFA IN ALL PATIENTS TO AVOID THE NEED FOR PACING FROM AN RV CATHETER. NO FURTHER COMPLICATIONS OCCURRED THEREAFTER. NO PATIENT SUFFERED FROM PERIPROCEDURAL STROKE, PERSISTING (> 24 H) PHRENIC NERVE PALSY, OR ATRIOESOPHAGEAL FISTULA IN ANY GROUP. AT 12 MONTHS AFTER THE PVI, A TOTAL OF 54/200 (27.0%) PATIENTS HAD A RECURRENCE OF ANY ATRIAL TACHYCARDIA AND REQUIRED A REDO PROCEDURE. MAURHOFER, J., KUEFFER, T., MADAFFARI, A., STETTLER, R., STEFANOVA, A., SEILER, J., THALMANN, G., KOZHUHAROV, N., GALUSZKA, O., SERVATIUS, H., HAEBERLIN, A., NOTI, F., TANNER, H., ROTEN, L., ET REICHLIN, T. (2023). PULSED-FIELD VS. CRYOBALLOON VS. RADIOFREQUENCY ABLATION: A PROPENSITY SCORE MATCHED COMPARISON OF ONE-YEAR OUTCOMES AFTER PULMONARY VEIN ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 67(2), 389-397. HTTPS://DOI.ORG/10.1007/S10840-023-01651-4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706794 FARAWAVE PULSED FIELD ABLATION CATHETER CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention