BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 22290844 · Received June 19, 2025

    Report

    Report Number
    2029046-2025-02001
    Event Type
    Injury
    Date Received
    June 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: LI K, SHI Y, WANG X, YE P, HAN B, JIANG W, ZHANG Y, ZHENG Q, JI A, ZHANG M, WANG Y, WU S, XU K, QIN M, LIU X, HOU X. AGGRESSIVE ABLATION VS. REGULAR ABLATION FOR PERSISTENT ATRIAL FIBRILLATION: A MULTICENTRE REAL-WORLD COHORT STUDY. EUROPACE. 2025 MAR 5;27(3):EUAF045. DOI: 10.1093/EUROPACE/EUAF045. PMID: 40048703; PMCID: PMC11920505. 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: FIELD D4. CATALOG SHOULD BE UNK_SMART TOUCH BIDIRECTIONAL SF. 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 AND THE FOLLOWING CITATION WAS REVIEWED: LI K, SHI Y, WANG X, YE P, HAN B, JIANG W, ZHANG Y, ZHENG Q, JI A, ZHANG M, WANG Y, WU S, XU K, QIN M, LIU X, HOU X. AGGRESSIVE ABLATION VS. REGULAR ABLATION FOR PERSISTENT ATRIAL FIBRILLATION: A MULTICENTRE REAL-WORLD COHORT STUDY. EUROPACE. 2025 MAR 5;27(3):EUAF045. DOI: 10.1093/EUROPACE/EUAF045. PMID: 40048703; PMCID: PMC11920505. BACKGROUND AND PURPOSE: THE STUDY AIMS TO ASSESS THE IMPACT OF THE AGGRESSIVE ABLATION STRATEGY ON THE CLINICAL OUTCOMES OF PATIENTS WITH PERAF, USING REAL-WORLD CLINICAL DATA. METHODS AND RESULTS: AMONG 4833 PERAF PATIENTS UNDERGOING CATHETER ABLATION AT 10 CENTRES, TWO GROUPS WERE DEFINED: REGULAR ABLATION (PVI-ONLY OR PVI PLUS ANATOMICAL ABLATION) AND AGGRESSIVE ABLATION (ANATOMICAL PLUS ELECTROGRAM-GUIDED ABLATION), WITH 1560 PATIENTS EACH AFTER PROPENSITY SCORE (PS) MATCHING. THE PRIMARY ENDPOINT WAS 12-MONTH AF/ATRIAL TACHYCARDIA (AT) RECURRENCE-FREE SURVIVAL OFF ANTI-ARRHYTHMIC DRUGS AFTER A SINGLE PROCEDURE. ADDITIONAL PS MATCHING WAS PERFORMED WITHIN THE REGULAR GROUP BETWEEN PVI-ONLY AND ANATOMICAL ABLATION (N = 455 EACH). FURTHERMORE, ANATOMICAL ABLATION FROM THE REGULAR GROUP WAS INDEPENDENTLY MATCHED WITH AGGRESSIVE ABLATION (N = 1362 EACH). AT 12 MONTHS, THE AGGRESSIVE GROUP SHOWED SUPERIOR AF/AT-FREE SURVIVAL (66.2% VS. 59.3%, P < 0.001; HR 0.745), SIMILAR AT RECURRENCE (12.0% VS. 11.3%, P = 0.539), AND SIGNIFICANTLY HIGHER PROCEDURAL AF TERMINATION (67.0% VS. 21.0%, P < 0.001) THAN REGULAR GROUP. MOREOVER, PATIENTS WITH AF TERMINATION HAD IMPROVED AF/AT-FREE SURVIVAL (72.3% VS. 55.2%, P < 0.001). SAFETY ENDPOINTS DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO GROUPS. BOTH THE ABLATION OUTCOMES AND AF TERMINATION RATE SHOWED INCREASING TRENDS WITH THE EXTENT OF ABLATION AGGRESSIVENESS BUT DECLINED WITH EXTREMELY AGGRESSIVE ABLATION. AFTER ADDITIONAL PS MATCHING, WITHIN THE REGULAR GROUP, NO STATISTICAL DIFFERENCES WERE OBSERVED THOUGH AF/AT-FREE SURVIVAL IN THE ANATOMICAL GROUP WAS SLIGHTLY HIGHER THAN THE PVI-ONLY GROUP (60.7% VS. 55.6%, P = 0.122); WHILE AGGRESSIVE ABLATION SHOWED IMPROVED AF/AT-FREE SURVIVAL COMPARED TO ANATOMICAL ABLATION ALONE FROM REGULAR GROUP (67.5% VS. 59.9%, P < 0.001). CONCLUSION: AGGRESSIVE ABLATION ACHIEVED MORE FAVOURABLE OUTCOMES THAN REGULAR ABLATION, AND MODERATELY AGGRESSIVE ABLATION MAY BE ASSOCIATED WITH BETTER CLINICAL OUTCOMES. AF TERMINATION IS A RELIABLE ABLATION ENDPOINT. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF (STSF) OTHER BWI DEVICES: THERMOCOOL SMARTTOUCH (ST), PENTARAY CATHETER. NON-BWI DEVICES: SL1-TYPE SWARTZ SHEATHS (ST. JUDE MEDICAL, ST. PAUL, MN, USA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK_SMART TOUCH BIDIRECTIONAL SF: - THE MOST COMMON ADVERSE EVENTS WERE VASCULAR COMPLICATIONS, INCLUDING 35 CASES OF HEMATOMA AT THE ACCESS SITE, 7 ARTERIOVENOUS FISTULAS, AND 6 PSEUDOANEURYSMS. SERIOUS ADVERSE EVENTS INCLUDED 7 TRANSIENT ISCHEMIC ATTACKS AND 10 PERICARDIAL EFFUSIONS, ALL OF WHICH WERE TREATED CONVENTIONALLY WITH NO LONG-TERM SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864712 SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SL1-TYPE SWARTZ SHEATHS| UNK_PENTARAY