BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL

    MDR report key: 24071757 · Received January 14, 2026

    Report

    Report Number
    2029046-2026-00158
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    October 24, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LEE KH, YAGISHITA A, SAKAMA S, KAZUMA I, KITAZAWA T, IKARI Y, YOSHIOKA K. FEASIBILITY OF HYBRIDING VERY HIGH-POWER SHORT-DURATION AND ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION. J ARRHYTHM. 2025 OCT 24;41(5):E70213. DOI: 10.1002/JOA3.70213. PMID: 41158603; PMCID: PMC12557459. 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 (01) GTIN IS NOT AVAILABLE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LEE KH, YAGISHITA A, SAKAMA S, KAZUMA I, KITAZAWA T, IKARI Y, YOSHIOKA K. FEASIBILITY OF HYBRIDING VERY HIGH-POWER SHORT-DURATION AND ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION. J ARRHYTHM. 2025 OCT 24;41(5):E70213. DOI: 10.1002/JOA3.70213. PMID: 41158603; PMCID: PMC12557459. BACKGROUND: A NOVEL TEMPERATURE-CONTROLLED RADIOFREQUENCY (RF) CATHETER ENABLES PULMONARY VEIN ISOLATION (PVI) USING VERY HIGH-POWER SHORT-DURATION (VHPSD) ABLATION, REDUCING ESOPHAGEAL INJURY RISK BUT RAISING CONCERNS ABOUT LESION DURABILITY IN THICKER ATRIAL MYOCARDIUM. OBJECTIVE: THIS STUDY AIMED TO ASSESS THE EFFICACY AND SAFETY OF A HYBRID APPROACH THAT INTEGRATES CONVENTIONAL ABLATION INDEX (AI)-GUIDED PVI WITH VHPSD ABLATION. METHODS: THIS PROSPECTIVE, SINGLE-CENTER STUDY ENROLLED 160 CONSECUTIVE PATIENTS WITH ATRIAL FIBRILLATION (AF) BETWEEN JANUARY 2023 AND DECEMBER 2023, WHO WERE ALLOCATED INTO TWO GROUPS. GROUP 1 (N=80) UNDERWENT CONVENTIONAL AI-GUIDED PVI USING A 40W SETTING, WHILE GROUP 2 (N=80) RECEIVED A HYBRID APPROACH COMBINING 90 AND 50W ABLATION WITH A TEMPERATURE-CONTROLLED RF CATHETER (QDOT MICRO, BIOSENSE WEBSTER INC., DIAMOND BAR, CA). CONCLUSIONS: THE INTEGRATION OF ABLATION INDEX-GUIDED ABLATION WITH VHPSD ABLATION, UTILIZING A NOVEL TEMPERATURE-CONTROLLED RF CATHETER, SIGNIFICANTLY REDUCES PROCEDURAL DURATION WHILE MAINTAINING SAFETY AND EFFICACY COMPARABLE TO CONVENTIONAL AIGUIDED PVI. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING A QDOT MICRO CATHETER (BIOSENSE WEBSTER) OTHER BWI PRODUCTS: MULTIELECTRODE MAPPING CATHETER (OCTARAY NAV; BIOSENSE WEBSTER), CARTO3 VERSION 7 CONFIDENSE MODULE (BIOSENSE WEBSTER), THERMOCOOL SMARTTOUCH STSF (BIOSENSE WEBSTER), STOCKERT 70 RF GENERATOR (BIOSENSE WEBSTER), VIZIGO SHEATH (BIOSENSE WEBSTER) NON-BWI DEVICES: RF NEEDLE (BAYLIS MEDICAL, MONTREAL, QC, CANADA), 8-F LONG SHEATH (SL-0; SJM, MINNEAPOLIS, MN, USA), ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: HAD CARDIAC TAMPONADE. NO INTERVENTION MENTIONED. QTY 1: HAD PERICARDITIS. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128286 SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening UNK_CARTO 3.| UNK_CARTO VIZIGO SHEATH.| UNK_OCTARAY NAV.| UNK_QDOT MICRO.| UNK_STOCKERT.