BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24090110 · Received January 15, 2026

    Report

    Report Number
    2029046-2026-00196
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    October 28, 2025
    Report Date
    January 15, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4. CATALOG: UNK_SMART TOUCH BIDIRECTIONAL SF. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CUI L, WANG H, LI J, YU H, SONG H, CHU Y, DONG S. EFFECT OF MITRAL ISTHMUS ABLATION ON RECURRENCE RATES IN HIGH-BURDEN PAROXYSMAL ATRIAL FIBRILLATION. MED SCI MONIT. 2025 OCT 28;31:E950108. DOI: 10.12659/MSM.950108. PMID: 41146408; PMCID: PMC12579435. 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CUI L, WANG H, LI J, YU H, SONG H, CHU Y, DONG S. EFFECT OF MITRAL ISTHMUS ABLATION ON RECURRENCE RATES IN HIGH-BURDEN PAROXYSMAL ATRIAL FIBRILLATION. MED SCI MONIT. 2025 OCT 28;31:E950108. DOI: 10.12659/MSM.950108. PMID: 41146408; PMCID: PMC12579435. BACKGROUND: PATIENTS WITH HIGH-BURDEN PAROXYSMAL ATRIAL FIBRILLATION (AF) HAVE A HIGHER RATE OF AF RECURRENCE AFTER CATHETER ABLATION THAN DO THOSE WITH A LOWER AF BURDEN. THE BLOCKADE RATE OF MITRAL ISTHMUS (MI) ABLATION CAN CONTRIBUTE TO THE MAINTENANCE OF SINUS RHYTHM AND BE HIGH BASED ON THE ETHANOL INFUSION OF THE VEIN OF MARSHALL. OBJECTIVE: IN THIS STUDY, WE AIMED TO COMPARE OUTCOMES FROM PVI WITH AND WITHOUT MI ABLATION FOR HIGH-BURDEN PAROXYSMAL AF. METHODS: PATIENTS WHO RECEIVED A DIAGNOSIS OF HIGH-BURDEN PAROXYSMAL AF BY ELECTROCARDIOGRAPH (ECG) RECORDING AND UNDERWENT CATHETER ABLATION FOR THE FIRST TIME WERE RECRUITED FROM JANUARY 2023 TO SEPTEMBER 2023. PATIENTS UNDERGOING THE ABLATION STRATEGY OF BILATERAL PVI ALONE WERE INCLUDED IN THE ¿2C¿ GROUP, WHILE PATIENTS WHO UNDERWENT BILATERAL PVI PLUS LINEAR ABLATION OF THE MI WERE INCLUDED IN THE ¿2C1L¿ GROUP (FIGURE 1). HIGH-BURDEN PAROXYSMAL AF WAS DEFINED AS ³4 SELF-TERMINATING EPISODES OF AF IN THE PRECEDING 6 MONTHS, WITH ³1 EPISODE LASTING OVER 6 H, CONFIRMED BY ECG RECORDING [7,8,13]. TO MITIGATE SELECTION BIAS, A PROPENSITY SCORE MATCHING TECHNIQUE WAS APPLIED USING A 2: 1 MATCHING RATIO BETWEEN THE 2C GROUP AND 2C1L GROUP. THIS APPROACH INCORPORATED VARIABLES SUCH AS AGE, SEX, DURATION OF AF, CHA2DS2-VASC SCORE (CONGESTIVE HEART FAILURE, HYPERTENSION, AGE ³75 YEARS, DIABETES MELLITUS, STROKE/TRANSIENT ISCHEMIC ATTACK/THROMBOEMBOLISM, VASCULAR DISEASE, AGE 65 TO 74 YEARS, SEX CATEGORY [FEMALE]), AND LEFT ATRIUM DIAMETER. THE MATCHING PROCESS WAS CONDUCTED WITHIN A PROPENSITY SCORE CALIPER OF 0.05. THE INCLUSION CRITERIA WERE AS FOLLOWS: (1) AGE BETWEEN 18 AND 80 YEARS, AND (2) SYMPTOMATIC HIGHBURDEN AF INTOLERANT TO ³1 ANTIARRHYTHMIC MEDICATION. PATIENTS WERE EXCLUDED IF THEY HAD SEVERE STRUCTURAL HEART DISEASE OR LEFT ATRIAL DIAMETER EXCEEDING 60 MM OR VOLUME ³200 ML. THE RESEARCH ADHERED TO THE PRINCIPLES OUTLINED IN THE DECLARATION OF HELSINKI AND RECEIVED APPROVAL FROM THE ETHICS COMMITTEE OF HENAN PROVINCIAL PEOPLE¿S HOSPITAL (NUMBER 18 [2025], 2025.01.16). PRIOR TO UNDERGOING THE PROCEDURES, ALL PATIENTS PROVIDED THEIR WRITTEN INFORMED CONSENT. THE MEAN DURATION FOLLOW-UP VISITS WERE SCHEDULED AT 3, 6, 9, AND 12 MONTHS FOR CLINICAL ASSESSMENTS AND 12-LEAD ECGS AT 6, 9, AND 12 MONTHS. CONCLUSIONS: IN PATIENTS WITH HIGH-BURDEN PAROXYSMAL AF, PVI COMBINED WITH MI BLOCKADE RESULTED IN A HIGHER RATE OF FREEDOM FROM AF/ATRIAL FLUTTER/ATRIAL TACHYCARDIA AT 12 MONTHS AFTER THE PROCEDURE THAN DID PVI ALONE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: (THERMOCOOL SMARTTOUCH SF; BIOSENSE WEBSTER) OTHER BWI PRODUCTS: STEERABLE DECAPOLAR CATHETER (DECANAV; BIOSENSE WEBSTER, IRVINE, CA, USA),ECHOCARDIOGRAPHY CATHETER (SOUNDSTAR; BIOSENSE WEBSTER), PENTARAY CATHETER (BIOSENSE WEBSTER) NON-BWI DEVICES: SWARTZ SHEATH (ABBOTT, CHICAGO, IL, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 PATIENT EXPERIENCED PERICARDIAL TAMPONADE, WHICH WAS SUCCESSFULLY MANAGED WITH PERICARDIOCENTESIS, IN THE 2C1L GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151543 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L ABBOTT SWARTZ SHEATH| UNK DECANAV CATHETER| UNK_PENTARAY| UNK_SOUNDSTAR