BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 22310005 · Received June 23, 2025

    Report

    Report Number
    2029046-2025-02051
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 23, 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HU Y, LI C, LI Y, WU X, LUO Y, ZHAO F, YAO S, YU W, HE B, LU Z. STEPS TO IMPROVE THE OUTCOME OF A SINGLE ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION: SIGNIFICANCE OF A BURST STIMULATION-GUIDED ABLATION STRATEGY. INT J CARDIOL. 2025 JUN 1;428:133132. DOI: 10.1016/J.IJCARD.2025.133132. EPUB 2025 MAR 6. PMID: 40056939. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. NOTE: FIELD D4. CATALOG SHOULD BE UNK_SMART TOUCH UNIDIRECTIONAL SF. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HU Y, LI C, LI Y, WU X, LUO Y, ZHAO F, YAO S, YU W, HE B, LU Z. STEPS TO IMPROVE THE OUTCOME OF A SINGLE ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION: SIGNIFICANCE OF A BURST STIMULATION-GUIDED ABLATION STRATEGY. INT J CARDIOL. 2025 JUN 1;428:133132. DOI: 10.1016/J.IJCARD.2025.133132. EPUB 2025 MAR 6. PMID: 40056939. BACKGROUND: THE OUTCOME OF A SINGLE ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF) IS SUBOPTIMAL. THE VALUE OF BURST STIMULATION AND ADDITIONAL ABLATION FOLLOWING THE ISOLATION OF PULMONARY VEIN (PV) AND SUPERIOR VENA CAVA (SVC) REMAINS UNCLEAR. OBJECTIVE: THE AIM OF THIS STUDY WAS TO OPTIMIZE THE ABLATION STRATEGY AND IMPROVE THE OUTCOME OF A SINGLE PROCEDURE FOR PAF. METHODS: THIS RETROSPECTIVE STUDY INVOLVED 404 PAF PATIENTS WHO UNDERWENT RADIOFREQUENCY ABLATION, AND WERE DIVIDED INTO GROUP 1 (PV + SVC ISOLATION, N = 81) AND GROUP 2 (PV + SVC ISOLATION + BURST STIMULATION-GUIDED ABLATION, N = 323). IN GROUP 2, ADDITIONAL LINEAR ABLATION WAS PERFORMED IF ATRIAL FIBRILLATION (AF) OR ATRIAL FLUTTER (AFL) PERSISTED OR WAS INDUCED BY BURST STIMULATION AFTER PV AND SVC ISOLATION. CONCLUSIONS: ADDITIONAL STEPWISE LINEAR ABLATION GUIDED BY BURST STIMULATION SIGNIFICANTLY IMPROVED THE OUTCOME OF A SINGLE ABLATION PROCEDURE FOR PAF. 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: 20-POLE CATHETER (PENTARAY, BIOSENSE WEBSTER) AND CARTO SYSTEM (BIOSENSE WEBSTER, DIAMOND BAR, CA). NON-BWI DEVICES: 8.5F-LONG SWARTZ SHEATHS (L1-TYPE, (B)(6) MEDICAL, (B)(6)). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 2: 2 PATIENTS PATIENTS EXPERIENCED PROCEDURE-RELATED CARDIAC PERFO RATION, LEADING TO HEMOPERICARDIUM, WHICH WAS TREATED WITH CARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219076 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R