BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 24027725 · Received January 9, 2026

    Report

    Report Number
    2029046-2026-00102
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    November 7, 2025
    Report Date
    January 9, 2026
    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 CITE HAS BEEN REVIEWED: LIU W, WANG A, LI Q, ZHANG Q, CHEN S, WEI Y, LU X, WU X, DAI B, LIU S, ZHOU G. LONG-TERM OUTCOME OF CATHETER ABLATION IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION AND FUNCTIONAL TRICUSPID REGURGITATION. FRONT CARDIOVASC MED. 2025 NOV 7;12:1600238. DOI: 10.3389/FCVM.2025.1600238. PMID: 41282353; PMCID: PMC12634592. 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 CITE HAS BEEN REVIEWED: LIU W, WANG A, LI Q, ZHANG Q, CHEN S, WEI Y, LU X, WU X, DAI B, LIU S, ZHOU G. LONG-TERM OUTCOME OF CATHETER ABLATION IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION AND FUNCTIONAL TRICUSPID REGURGITATION. FRONT CARDIOVASC MED. 2025 NOV 7;12:1600238. DOI: 10.3389/FCVM.2025.1600238. PMID: 41282353; PMCID: PMC12634592. BACKGROUND: ATRIAL FIBRILLATION (AF) AND TRICUSPID REGURGITATION (TR) FREQUENTLY COEXIST AND MUTUALLY WORSEN EACH OTHER. HOWEVER, THE LONG-TERM EFFECTS OF FUNCTIONAL TRICUSPID REGURGITATION (FTR) ON AF RECURRENCE AND THE IMPROVEMENT OF TR AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA) REMAIN UNCLEAR. OBJECTIVE: THIS STUDY AIMED TO EVALUATE LONG-TERM OUTCOMES OF RFCA IN PSAF PATIENTS WITH FTR, IDENTIFY PREDICTORS OF AF RECURRENCE, AND ASSESS THE THERAPEUTIC IMPACT ON FTR. METHODS: THIS RETROSPECTIVE, SINGLE-CENTER OBSERVATIONAL STUDY INVOLVED 1,690 PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION (PSAF) WHO UNDERWENT AF ABLATION BETWEEN JANUARY 2012 AND JUNE 2022. 153 PATIENTS WITH SIGNIFICANT FTR WERE PROPENSITY MATCHING 153 PATIENTS WITH NO OR MILD FTR BASED ON AGE, BODY MASS INDEX, AND MITRAL REGURGITATION (MR) SEVERITY. PATIENTS WERE FOLLOWED UP FOR AT LEAST 1 YEAR. PROCEDURAL SUCCESS WAS DEFINED AS FREEDOM FROM ANY ATRIAL TACHYARRHYTHMIA (>30 S) AFTER THE 3-MONTH BLANKING PERIOD, OFF ANTIARRHYTHMIC DRUGS. SIGNIFICANT FTR WAS DEFINED AS MODERATE TO SEVERE TR. SIGNIFICANT TR IMPROVEMENT WAS DEFINED AS A REDUCTION IN TR SEVERITY BY =2 GRADES FROM PRE- TO POST-ABLATION. CONCLUSIONS: SIGNIFICANT FTR WAS AN INDEPENDENT PREDICTOR OF AF RECURRENCE IN PATIENTS WITH PSAF UNDERGOING RFCA. THE LONG-TERM SUCCESS WAS POOR IN THE SUBGROUPS OF SIGNIFICANT FTR AND THOSE WITH VENTRICULAR FTR. FURTHERMORE, SUCCESSFUL RFCA WAS ASSOCIATED WITH SIGNIFICANTLY IMPROVED FTR IN PATIENTS WITH PSAF. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING A IRRIGATED RADIOFREQUENCY ABLATION CATHETER (THERMO-COOL, THERMO-COOL SMART-TOUCH, OR THERMO-COOL SMART-TOUCH SF, BIOSENSE WEBSTER, INC.). OTHER BWI PRODUCTS: LASSO CATHETER (BIOSENSE WEBSTER, INC.), PENTARAY CATHETER (BIOSENSE WEBSTER, INC.), THREE-DIMENSIONAL NAVIGATION SYSTEM (CARTO OR CARTO 3, BIOSENSE WEBSTER, INC.). NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 3: PERICARDIAL TAMPONADE. 1 PATIENT IN THE NO OR MILD FTR GROUP AND 2 PATIENTS IN THE SIGNIFICANT FTR GROUP (BOTH RESOLVED AFTER PERICARDIAL DRAINAGE; 1 ADDITIONAL PATIENT WITH SIGNIFICANT FTR RECOVERED SPONTANEOUSLY WITHIN 1 WEEK POSTPROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81687 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R UNK_CARTO 3.| UNK_LASSO.| UNK_PENTARAY.