BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL

    MDR report key: 23038626 · Received September 12, 2025

    Report

    Report Number
    2029046-2025-03121
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    January 1, 2023
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: LIU J, XIA Y, GUO J, LI X, NIU G, CHEN K, YAO Y. A PRELIMINARY EXPLORATORY STUDY OF QUANTITATIVE ABLATION OF ELECTRICAL ISOLATION OF SUPERIOR VENA CAVA. DEPARTMENT OF CARDIOLOGY. DOI:10. 3969/ J. ISSN. 1007-5410. 2023. 05. 005. 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. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: LIU J, XIA Y, GUO J, LI X, NIU G, CHEN K, YAO Y. A PRELIMINARY EXPLORATORY STUDY OF QUANTITATIVE ABLATION OF ELECTRICAL ISOLATION OF SUPERIOR VENA CAVA. DEPARTMENT OF CARDIOLOGY. DOI:10. 3969/ J. ISSN. 1007-5410. 2023. 05. 005. BACKGROUND: AI IS CURRENTLY THE MOST COMMONLY USED ENERGY DELIVERY PARAMETER IN RF ABLATION OF ATRIAL FIBRILLATION. RADIOFREQUENCY ABLATION USING AN AI GUIDANCE STRATEGY CAN NOT ONLY ACHIEVE EFFECTIVE ATRIAL MUSCLE INJURY, BUT ALSO PREVENT SURROUNDING TISSUE DAMAGE CAUSED BY EXCESSIVE ABLATION. OBJECTIVE: TO INVESTIGATE THE QUANTITATIVE ABLATION PARAMETERS OF SUPERIOR VENA CAVA ELECTRICAL ISOLATION (SVCI) BY RADIOFREQUENCY ABLATION AFTER HIGH-DENSITY MAPPED ELECTRICAL CONDUCTION BETWEEN THE RIGHT ATRIUM AND SUPERIOR VENA CAVA (SVC) FOR ATRIAL FIBRILLATION (AF) PATIENTS AND ANALYZE ITS SAFETY AND EFFICACY. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY. PATIENTS WITH AF WHO CONSECUTIVELY UNDERWENT RADIOFREQUENCY ABLATION OF SVCI FROM OCTOBER 2020 TO AUGUST 2021 WERE INCLUDED. FIRST, ANATOMICAL SITES OF ELECTRICAL CONDUCTION BETWEEN THE RIGHT ATRIUM AND SVC, THE FUNCTIONAL SINOATRIAL NODE, AND THE PHRENIC NERVE WERE RECONSTRUCTED BY THE THREE-DIMENSIONAL HIGH DENSITY ELECTROANATOMICAL MAPPING UNDER THE SINUS RHYTHM. THEN, ABLATION WAS PERFORMED AT THE OPENING OF SVC GUIDED BY THE CONDUCTION BREAKTHROUGH POINT FROM THE RIGHT ATRIUM TO SVC TO COMPLETE SVCI. LASTLY, RADIOFREQUENCY ABLATION ENERGY INDICATED BY ABLATION INDEX (AI) IN 8 SEGMENTS OF SVC (SUPERIOR VIEW) WAS EVALUATED BY OFFLINE ANALYSES METHOD. THE SAFETY AND EFFICACY OF SVCI WAS OBSERVED. CONCLUSIONS: SVCI CAN BE SAFELY AND EFFECTIVELY PERFORMED BY SEGMENTAL ABLATION OF SVC WITH AI UNDER THE SUPERIOR VENA CAVA IS THE MOST COMMON NON-PULMONARY VEIN TRIGGER FOCUS OF ATRIAL FIBRILLATION (REFERRED TO AS "ATRIAL FIBRILLATION"), AND SUPERIOR VENA CAVA ISOLATION (SVCI) CAN IMPROVE THE SUCCESS RATE OF AF ABLATION THERAPY. BECAUSE THE SINOATRIAL NODE AND PHRENIC NERVE ARE ADJACENT TO THE SUPERIOR VENA CAVA, EXCESSIVE ABLATION ENERGY RELEASE CAN LEAD TO SINOATRIAL NODE AND PHRENIC NERVE INJURY. RECENT STUDIES HAVE SHOWN THAT SVCI CAN BE SAFELY AND EFFECTIVELY ACHIEVED BY USING HIGH-DENSITY MAPPING OF THE RIGHT ATRIUM AND SUPERIOR VENA CAVA ELECTRICAL CONDUCTION FOLLOWED BY SUPERIOR VENA CAVA ABLATION. IN ADDITION, ABLATION INDEX IS THE MOST COMMON QUANTITATIVE PARAMETER OF RADIOFREQUENCY ABLATION ENERGY RELEASE, WHICH GUIDES THE SAFE AND EFFECTIVE COMPLETION OF PULMONARY VEIN ISOLATION DURING SURGERY AND IS WIDELY USED IN RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION. HOWEVER, THE USE OF AI IN SVCI HAS NOT BEEN REPORTED. THEREFORE, THIS STUDY RETROSPECTIVELY ANALYZED THE DIFFERENT AI VALUES OF SUPERIOR VENA CAVA DURING RADIOFREQUENCY ABLATION GUIDED BY HIGH-DENSITY MAPPING TO COMPLETE SVCI AND ANALYZED ITS SAFETY AND EFFICACY. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING AN ABLATION CATHETER WITH PRESSURE GUIDANCE (SMARTACH, JOHNSON & JOHNSON, USA) OTHER BWI PRODUCTS: CARTO3 THREE-DIMENSIONAL MAPPING SYSTEM. NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 PATIENT HAD PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960131 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.| UNK_SMART TOUCH UNIDIRECTIONAL.