BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF NON NAV

    MDR report key: 22919893 · Received August 28, 2025

    Report

    Report Number
    2029046-2025-02914
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    May 20, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: DERVAL N, TIXIER R, DUCHATEAU J, BOUTEILLER X, LOOCK T, DENIS A, CHAUVEL R, BOUYER B, ARNAUD M, YOKOYAMA M, KOWALEWSKI C, MONACO C, ASCIONE C, SACHER F, HOCINI M, JAÏS P, HAÏSSAGUERRE M, PAMBRUN T. MARSHALL-PLAN ABLATION STRATEGY VERSUS PULMONARY VEIN ISOLATION IN PERSISTENT AF: A RANDOMIZED CONTROLLED TRIAL. CIRC ARRHYTHM ELECTROPHYSIOL. 2025 MAY;18(5):E013427. DOI: 10.1161/CIRCEP.124.013427. EPUB 2025 MAY 20. PMID: 40392905; PMCID: PMC12094258. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. NOTE: FOR FIELD D4.UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: DERVAL N, TIXIER R, DUCHATEAU J, BOUTEILLER X, LOOCK T, DENIS A, CHAUVEL R, BOUYER B, ARNAUD M, YOKOYAMA M, KOWALEWSKI C, MONACO C, ASCIONE C, SACHER F, HOCINI M, JAÏS P, HAÏSSAGUERRE M, PAMBRUN T. MARSHALL-PLAN ABLATION STRATEGY VERSUS PULMONARY VEIN ISOLATION IN PERSISTENT AF: A RANDOMIZED CONTROLLED TRIAL. CIRC ARRHYTHM ELECTROPHYSIOL. 2025 MAY;18(5):E013427. DOI: 10.1161/CIRCEP.124.013427. EPUB 2025 MAY 20. PMID: 40392905; PMCID: PMC12094258. BACKGROUND: BEYOND PULMONARY VEIN (PV) ISOLATION, THE OPTIMAL ABLATION STRATEGY FOR PERSISTENT ATRIAL FIBRILLATION (AF) REMAINS POORLY DEFINED. THE PURPOSE OF THIS STUDY WAS TO COMPARE 2 ABLATION STRATEGIES IN THE TREATMENT OF PATIENTS WITH PERSISTENT AF: A COMPREHENSIVE ABLATION STRATEGY BASED ON ANATOMIC CONSIDERATIONS VERSUS PV ISOLATION ALONE. METHODS: THE MARSHALL-PLAN TRIAL IS A PROSPECTIVE, RANDOMIZED, PARALLEL-GROUP, CONTROLLED CLINICAL TRIAL OF SUPERIORITY CONDUCTED AT THE BORDEAUX UNIVERSITY HOSPITAL. CONSECUTIVE PATIENTS WITH SYMPTOMATIC, DOCUMENTED PERSISTENT AF WERE INCLUDED AND RANDOMIZED INTO 2 ARMS: MARSHALL-PLAN CONSISTING OF PV ISOLATION WITH ADDITIONAL ABLATION INCLUDING VEIN OF MARSHALL ETHANOL INFUSION, AND LINES OF BLOCK AT THE MITRAL, DOME, AND CAVOTRICUSPID ISTHMUSES VERSUS PV ISOLATION ALONE. THE MAIN OUTCOME WAS THE 1-YEAR FREEDOM FROM ANY ARRHYTHMIA (ATRIAL FIBRILLATION/ATRIAL TACHYCARDIA >30 SECONDS) AFTER A SINGLE ABLATION PROCEDURE WITH OR WITHOUT ANY ANTIARRHYTHMIC MEDICATION AT 12 MONTHS. CONCLUSIONS: IN THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL, THE MARSHALL-PLAN STRATEGY WAS SIGNIFICANTLY SUPERIOR TO A PV ISOLATION STRATEGY AT 12 MONTHS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF OTHER BWI: CARTO-3 MAPPING SYSTEM, PENTARAY NAV OR OCTARAY NAV ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_THERMOCOOL SF NON NAV DEVICES: -QTY: 1 PATIENT HAD OESOPHAGEAL FISTULAE ASSOCIATED WITH MEDIASTINITIS; NO INTERVENTION PROVIDED. -QTY: 1 PATIENT HAD SEVERE GROIN HEMATOMA; REQUIRING RADIOEMBOLIZATION AND BLOOD TRANSFUSION. -QTY: 1 PATIENT HAD FEMORAL AV FISTULA. NO INTERVENTION WAS PROVIDED. -QTY: 7 PATIENTS HAD PERICARDITIS; NO INTERVENTION WAS PROVIDED. -QTY: 4 PATIENT HAD HYPERTHERMIA; NO INTERVENTION WAS PROVIDED. -QTY: 3 PATIENT EXPERIENCED NAUSEA; NO INTERVENTION WAS PROVIDED. -QTY: 2 PATIENT EXPERIENCED DYSPNEA; NO INTERVENTION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864346 THERMOCOOL SF NON NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R CARTO-3 MAPPING SYSTEM| OCTARAY NAV| PENTARAY NAV