BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 23203005 · Received October 2, 2025

    Report

    Report Number
    2029046-2025-03335
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    July 14, 2025
    Report Date
    October 2, 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

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: LI C, HU Y, LI Y, ZENG Z, YU W, ZHOU Z, QIU H, HE B, LU Z. EFFECTS OF CARDIONEUROABLATION FOR VASOVAGAL SYNCOPE: GANGLIONATED PLEXUS LOCALIZATION BY TENTATIVE ANATOMICAL ABLATION AND HIGH-FREQUENCY ELECTRICAL STIMULATION. BMC CARDIOVASC DISORD. 2025 JUL 14;25(1):505. DOI: 10.1186/S12872-025-04933-Z. PMID: 40660118; PMCID: PMC12257755. 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. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: LI C, HU Y, LI Y, ZENG Z, YU W, ZHOU Z, QIU H, HE B, LU Z. EFFECTS OF CARDIONEUROABLATION FOR VASOVAGAL SYNCOPE: GANGLIONATED PLEXUS LOCALIZATION BY TENTATIVE ANATOMICAL ABLATION AND HIGH-FREQUENCY ELECTRICAL STIMULATION. BMC CARDIOVASC DISORD. 2025 JUL 14;25(1):505. DOI: 10.1186/S12872-025-04933-Z. PMID: 40660118; PMCID: PMC12257755. BACKGROUND: CARDIONEUROABLATION IS INCREASINGLY BEING ADOPTED AS A TREATMENT FOR VASOVAGAL SYNCOPE (VVS). IDENTIFICATION OF THE CARDIAC GANGLIONATED PLEXUS (GP) IS A CRITICAL FACTOR INFLUENCING THE OUTCOME OF THE PROCEDURE. THIS STUDY SOUGHT TO COMPARE THE EFFICACY OF TENTATIVE ANATOMICAL ABLATION (TAA) AND HIGH-FREQUENCY ELECTRICAL STIMULATION (HFS) IN LOCATING THE GP. OBJECTIVE: THIS STUDY AIMS IS TO PRESENT A CASE OF 58 PATIENTS DIAGNOSED WITH VVS WHO UNDERWENT CNA TO COMPARE THE EFFICACY OF TAA AND HFS APPROACHES IN LOCATING THE GP DURING THE PROCEDURE. METHODS: A TOTAL OF 58 PATIENTS DIAGNOSED WITH VVS WERE CONSECUTIVELY ENROLLED, INCLUDING 46 PATIENTS WITH THE CARDIOINHIBITORY TYPE AND 12 PATIENTS WITH THE MIXED TYPE WHO EXHIBITED A SIGNIFICANT DECREASE IN HEART RATE (HR). THE FIRST 19 ENROLLED PATIENTS SIMULTANEOUSLY UNDERWENT HFS- AND TAA-GUIDED GP LOCALIZATION. ALL PATIENTS UNDERWENT ANATOMICAL GP ABLATION. CONCLUSIONS: IN GP LOCALIZATION, TAA-GUIDED RESPONSES DEMONSTRATED GREATER PRECISION AND WIDER DISTRIBUTION COMPARED TO HFS-GUIDED APPROACHES. ANATOMICAL GP ABLATION CAN SIGNIFICANTLY DECREASE AUTONOMIC TONE AND PREVENT SYNCOPE IN PATIENTS WITH VVS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: IRRIGATED CATHETER (THERMOCOOL SMARTTOUCH; BIOSENSE WEBSTER). OTHER BWI PRODUCTS: DECAPOLAR CATHETER, QUADRUPOLAR CATHETER, CARTO SYSTEM (BIOSENSE WEBSTER, (B)(6)). NON-BWI DEVICES: LONG SWARTZ SHEATHS (L1-TYPE, (B)(6) MEDICAL, MINNEAPOLIS, MN), ELECTROPHYSIOLOGICAL LABORATORY SYSTEM (LEAD EP, JINGJIANG INC., SICHUAN PROVINCE, CHINA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 49: 49 CASES OF SINUS ARREST LASTING MORE THAN 3 SECONDS. NO INTERVENTION MENTIONED. QTY 39: 39 CASES OF FIRST, SECOND-, OR THIRD-DEGREE ATRIOVENTRICULAR BLOCK. NO INTERVENTION MENTIONED. QTY 4: 4 CASES OF INTOLERABLE INCREASE IN HR. BETA-BLOCKERS WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621535 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other