BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL

    MDR report key: 23771104 · Received December 10, 2025

    Report

    Report Number
    2029046-2025-03955
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    August 14, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO. (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHEN W, ZHANG Y, QIAN W, LI C, WANG C, LI W, LI J, CHEN J, WEI Y, LIU Y, ZHAO Y, XU W. PULMONARY VEIN ISOLATION WITH OR WITHOUT EMPIRIC SUPERIOR VENA CAVA ISOLATION IN PATIENTS UNDERGOING ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: THE RANDOMIZED ESVCI-AF TRIAL. EUROPACE. 2025 SEP 1;27(9):EUAF175. DOI: 10.1093/EUROPACE/EUAF175. PMID: 40811582; PMCID: PMC12448917. 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. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT 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. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHEN W, ZHANG Y, QIAN W, LI C, WANG C, LI W, LI J, CHEN J, WEI Y, LIU Y, ZHAO Y, XU W. PULMONARY VEIN ISOLATION WITH OR WITHOUT EMPIRIC SUPERIOR VENA CAVA ISOLATION IN PATIENTS UNDERGOING ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: THE RANDOMIZED ESVCI-AF TRIAL. EUROPACE. 2025 SEP 1;27(9):EUAF175. DOI: 10.1093/EUROPACE/EUAF175. PMID: 40811582; PMCID: PMC12448917. BACKGROUND: ATRIAL FIBRILLATION (AF) IS THE MOST PREVALENT SUSTAINED ARRHYTHMIA AND IS A MAJOR CONTRIBUTOR TO CARDIOVASCULAR MORBIDITY AND MORTALITY. PULMONARY VEIN ISOLATION (PVI) REMAINS THE CORNERSTONE OF CATHETER ABLATION FOR SYMPTOMATIC PAROXYSMAL AF (PAF), OFFERING SUPERIOR RHYTHM CONTROL COMPARED TO ANTIARRHYTHMIC DRUGS. OBJECTIVE: THIS STUDY AIMED TO DETERMINE WHETHER ADDING EMPIRIC SVCI TO PVI IMPROVES FREEDOM FROM ATRIAL ARRHYTHMIA (ATA) RECURRENCE IN PATIENTS WITH PAF. METHODS: A TOTAL OF 302 PATIENTS WITH PAF, AGED 18 TO 75 YEARS, UNDERGOING INDEX ABLATION, WERE ENROLLED AND RANDOMIZED IN A 1:1 RATIO TO EITHER THE PVI PLUS SVCI GROUP OR THE PVI ALONE GROUP BETWEEN MAY 2021 AND FEBRUARY 2024. IN THE PVI PLUS SVCI GROUP, PVI WAS PERFORMED FIRST, FOLLOWED BY EMPIRIC SVCI. IN THE PVI ALONE GROUP, ONLY PVI WAS PERFORMED. AMONG 302 RANDOMIZED PATIENTS [MEDIAN (IQR) AGE, 64.9 (56.0 TO 70.0) YEARS, 165 MEN (54.6%)], 302 (100%) COMPLETED THE 3-MONTH BLANKING PERIOD AND CONTRIBUTED TO THE EFFICACY ANALYSIS. AFTER A MEDIAN FOLLOW-UP OF 20 MONTHS, THE RECURRENCE OF RATE OF ATAS DID NOT DIFFER SIGNIFICANTLY BETWEEN THE PVI PLUS SVCI GROUP (20/151 PATIENTS, 13.2%) AND PVI ALONE GROUP (29/151, 19.2%) WITHOUT TAKING ANTIARRHYTHMIC DRUGS (HAZARD RATIO, 0.68, 95% CONFIDENCE INTERVAL 0.38 TO 1.20, P = 0.182). SUBGROUP OUTCOMES ANALYSIS FURTHER DEMONSTRATED NO SIGNIFICANT INTERACTION ACROSS SUBGROUPS. CONCLUSIONS: AMONG PATIENTS WITH PAF UNDERGOING INITIAL ABLATION, THE ADDITION OF EMPIRIC SVCI TO PVI, COMPARED WITH PVI ALONE, DID NOT SIGNIFICANTLY IMPROVE FREEDOM FROM ATA RECURRENCE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: IRRIGATED-TIP, CONTACT FORCE CATHETERS (THERMOCOOL SMARTTOUCH CATHETER OR THERMOCOOL SMARTTOUCH SURROUND FLOW CATHETER, BIOSENSE-WEBSTER INC). OTHER BWI PRODUCTS: THREE-DIMENSIONAL MAPPING SYSTEM (CARTO3, BIOSENSE-WEBSTER INC.). NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK SMART TOUCH UNIDIRECTIONAL: QTY: 3 PATIENTS HAD CARDIAC TAMPONADE. 1 CASE REQUIRED PERICARDIOCENTESIS WHILE THE REMAINING 2 CASES WERE MANAGED CONSERVATIVELY AND RESOLVED SPONTANEOUSLY UNDER CLOSE OBSERVATION. QTY 1: 1 PATIENT EXPERIENCED POST-PROCEDURAL PHRENIC NERVE PARALYSIS, WHICH FULLY RESOLVED WITHIN 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108144 SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CARTO 3 SYSTEM