BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24757772 · Received April 1, 2026

    Report

    Report Number
    2029046-2026-01081
    Event Type
    Injury
    Date Received
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: JAIS P, NEUZIL P, SCHERR D, FRISON E, KNECHT S, BOVEDA S, DEISENHOFER I, MAURY P, DENEKE T, COCHET H, ROUSSET M, RENAUDEAU V, SAUER E, SERMESANT M, KAUTZNER J, ERHARD N, WICHTERLE D. PULSED FIELD VS RADIOFREQUENCY ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: THE BEAT PAROX-AF TRIAL. EUR HEART J. 2026 JAN 22:EHAF1115. DOI: 10.1093/EURHEARTJ/EHAF1115. EPUB AHEAD OF PRINT. PMID: 41568658. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: JAIS P, NEUZIL P, SCHERR D, FRISON E, KNECHT S, BOVEDA S, DEISENHOFER I, MAURY P, DENEKE T, COCHET H, ROUSSET M, RENAUDEAU V, SAUER E, SERMESANT M, KAUTZNER J, ERHARD N, WICHTERLE D. PULSED FIELD VS RADIOFREQUENCY ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: THE BEAT PAROX-AF TRIAL. EUR HEART J. 2026 JAN 22:EHAF1115. DOI: 10.1093/EURHEARTJ/EHAF1115. EPUB AHEAD OF PRINT. PMID: 41568658. BACKGROUND AND AIMS: THIS TRIAL COMPARED SINGLE-PROCEDURE EFFICACY AND SAFETY OF PULSED FIELD ABLATION (PFA) VS RADIOFREQUENCY ABLATION (RFA) IN PATIENTS WITH DRUG-RESISTANT PAROXYSMAL ATRIAL FIBRILLATION (AF). METHODS: BEAT PAROX-AF IS A EUROPEAN, MULTICENTRE, OPEN-LABEL, RANDOMIZED, CONTROLLED, SUPERIORITY TRIAL CONDUCTED ACROSS NINE EUROPEAN SITES. ELIGIBLE PATIENTS (AGED 18-80 YEARS) WITH SYMPTOMATIC, DRUG-RESISTANT PAROXYSMAL AF WERE RANDOMIZED (1:1) TO EITHER PFA (PENTASPLINE) OR RFA FOLLOWING THE CLOSE PROTOCOL (CONTACT FORCE SENSING CATHETER AND ELECTRO-ANATOMICAL MAPPING SYSTEM). THE PRIMARY ENDPOINT WAS THE SINGLE-PROCEDURE SUCCESS RATE AFTER 12 MONTHS DEFINED AS THE ABSENCE OF =30 S ATRIAL ARRHYTHMIA RECURRENCE, CARDIOVERSION, CLASS I/III ANTIARRHYTHMIC DRUG RESUMPTION AFTER A 2-MONTH BLANKING PERIOD, OR ANY REPEAT ABLATION. CONCLUSIONS: THIS RANDOMIZED TRIAL PERFORMED IN PATIENTS WITH PAROXYSMAL AF DID NOT DEMONSTRATE SUPERIOR EFFICACY OF SINGLE-SHOT PFA VS POINT-BY-POINT RFA USING THE CLOSE PROTOCOL REGARDING SINGLE-PROCEDURE FREEDOM FROM ATRIAL ARRHYTHMIAS, DESPITE FEWER SAFETY EVENTS BEING OBSERVED IN THIS STUDY WITH PFA. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: RFA PVI PROCEDURE DEVICE USED: CONTACT FORCE¿SENSING CATHETER (SMARTTOUCH® OR SMARTTOUCH® SURROUND FLOW). OTHER BWI DEVICE(S): CARTO® 3 SYSTEM (BIOSENSE WEBSTER). NON-BWI DEVICE(S): PFA PVI PROCEDURE DEVICE USED: FARAPULSE¿ ABLATION SYSTEM (BOSTON SCIENTIFIC©), PENTASPLINE ABLATION CATHETERS WITH DIAMETERS OF 31 MM OR 35 MM, GENERATOR AND THE DEDICATED DEFLECTABLE SHEATH (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_SMART TOUCH BIDIRECTIONAL SF DEVICE(S): QTY 1: 1 PARTICIPANT ALLOCATED TO RFA RECEIVED PFA BASED ON THE INVESTIGATOR¿S DECISION FOLLOWING THE DETECTION OF A SMALL, ASYMPTOMATIC PERICARDIAL EFFUSION DURING THE PROCEDURE. QTY 2: 2 CASES OF CARDIAC TAMPONADE IN RFA GROUP. QTY 1: 1 CASE OF OESOPHAGEAL BLEEDING (POTENTIALLY RELATED TO TRANSOESOPHAGEAL ECHOCARDIOGRAPHY) WERE OBSERVED. QTY 2: 2 CASES OF SEVERE PULMONARY VEIN STENOSIS (>70%) WERE REPORTED IN THE RFA GROUP, ALL INVOLVING THE LEFT INFERIOR PV. QTY 1: 1 TRANSIENT CASES OF PHRENIC NERVE PALSY WERE OBSERVED IN THE TRIAL IN RFA GROUP. QTY 9: 9 PATIENTS IN THE RFA GROUP, UNDERWENT REPEAT ABLATION PROCEDURES DUE TO RECURRENT AF. QTY 12: 12 PATIENTS IN THE RFA GROUP HAD STENOSIS >50%: 10 PATIENTS ONE VEIN, ONE PATIENT HAD STENOSIS IN TWO VEINS (BOTH LEFT-SIDED VEINS), AND ONE PATIENT IN THREE VEINS (LEFT INFERIOR PV AND BOTH RIGHT-SIDED VEINS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819356 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H