BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22901191 · Received August 26, 2025

    Report

    Report Number
    2029046-2025-02868
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 26, 2025
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. 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: KANAI M, HIGUCHI S, SAKAI M, MATSUI Y, HASEGAWA S, YAGISHITA D, SHODA M, YAMAGUCHI J. MID-TERM EFFECTS ON SINUS NODE FUNCTION FOLLOWING ADDITIONAL EMPIRICAL SUPERIOR VENA CAVA ISOLATION IN ATRIAL FIBRILLATION PATIENTS WITH SICK SINUS SYNDROME. J ARRHYTHM. 2025 JUN 30;41(4):E70126. DOI: 10.1002/JOA3.70126. PMID: 40599730; PMCID: PMC12207091. 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 NO LOT NUMBER WAS 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. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KANAI M, HIGUCHI S, SAKAI M, MATSUI Y, HASEGAWA S, YAGISHITA D, SHODA M, YAMAGUCHI J. MID-TERM EFFECTS ON SINUS NODE FUNCTION FOLLOWING ADDITIONAL EMPIRICAL SUPERIOR VENA CAVA ISOLATION IN ATRIAL FIBRILLATION PATIENTS WITH SICK SINUS SYNDROME. J ARRHYTHM. 2025 JUN 30;41(4):E70126. DOI: 10.1002/JOA3.70126. PMID: 40599730; PMCID: PMC12207091. BACKGROUND: THE SUPERIOR VENA CAVA (SVC) IS WELL ESTABLISHED AS A SIGNIFICANT NON-PULMONARY VEIN FOCUS IN PATIENTS WITH ATRIAL FIBRILLATION (AF).1 MIYAZAKI ET AL. HAVE INDICATED THAT THE SVC CAN FUNCTION BOTH AS A DRIVER AND A TRIGGER IN AF. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE LONG-TERM CLINICAL OUTCOMES OF SINUS NODE FUNCTION FOLLOWING ADDITIONAL EMPIRICAL SVCI IN AF PATIENTS WITH SSS. METHODS: IN THIS RETROSPECTIVE STUDY, 94 AF PATIENTS WITH SSS, WHO UNDERWENT PVI WITHOUT PRIOR PACEMAKER PLACEMENT, WERE DIVIDED INTO TWO GROUPS: THOSE WITH (N = 67, AGE 66.0 ± 9.3 YEARS, MALE 61%) AND WITHOUT (N = 27, AGE 66.6 ± 10.0 YEARS, MALE 63%) ADDITIONAL EMPIRICAL SVCI. SVCI WAS PERFORMED AT 25¿35 W, 10¿20 MM SUPERIOR TO THE EARLIEST SITES OF ACTIVATION DURING SINUS RHYTHM. THE PRIMARY ENDPOINT COMPARED ATRIAL TACHYARRHYTHMIA (ATA) RECURRENCE, PACEMAKER AVOIDANCE, AND 24-HOUR AMBULATORY MONITORING RESULTS BETWEEN THE SVCI AND NON-SVCI GROUPS. PREPROCEDURE MINIMUM HEART RATE (SVCI 37.6 ± 11.6 BPM VS. NON-SVCI 37.0 ± 9.9 BPM, P = 0.74) AND MAXIMUM PAUSE (SVCI 4.2 ± 2.7 SEC VS. NON-SVCI 3.6 ± 2.8 SEC, P = 0.15) WERE NOT DIFFERENT BETWEEN THE TWO GROUPS. DURING 36 MONTHS OF FOLLOW-UP AFTER THE LAST PROCEDURE, ATA RECURRENCE RATES (SVCI 33% VS. NON-SVCI 34%, P = 0.82) AND PACEMAKER AVOIDANCE RATES (SVCI 84% VS. NON-SVCI 93%, P = 0.32) WERE COMPARABLE BETWEEN THE TWO GROUPS. AT 36 MONTHS AFTER THE LAST PROCEDURE, MINIMUM HEART RATE (SVCI 48.7 ± 10.2 BPM VS. NON-SVCI 47.4 ± 8.3 BPM, P = 0.52) AND MAXIMUM PAUSE (SVCI 1.6 ± 1.0 SEC VS. NON-SVCI 1.6 ± 0.6 SEC, P = 0.33) REMAINED SIMILAR BETWEEN THE TWO GROUPS. CONCLUSIONS: IN THIS STUDY, THE ADDITION OF SVCI DID NOT SIGNIFICANTLY INCREASE THE NEED FOR PACEMAKER IMPLANTATION OR LEAD TO SINUS NODE DYSFUNCTION IN AF PATIENTS WITH SSS COMPARED TO PVI ALONE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: A 3.5-MM OPEN-IRRIGATED TIP CATHETER (THERMOCOOL, THERMOCOOL SF OR THERMOCOOL STSF; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA). OTHER BWI PRODUCTS: (CARTO3; BIOSENSE WEBSTER, DIAMOND BAR, CA, USA). NON-BWI DEVICES: UNKNOWN MANUFACTURER TWO LONG SHEATHS, ONE CIRCULAR MULTIELECTRODE CATHETER. 7 PATIENTS REQUIRED PACEMAKER IMPLANTATION DUE TO SYMPTOMATIC TACHYCARDIA-BRADYCARDIA SYNDROME ASSOCIATED WITH AF RECURRENCE. THESE WILL NOT BE CAPTURED SINCE THE SYNDROME WERE ASSOCIATED WITH AF RECURRENCE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 3: PHRENIC NERVE INJURY WAS OBSERVED IN 3 PATIENTS. NO INTERVENTION MENTIONED. HOWEVER, IT WAS REPORTED THAT ALL CASES RECOVERED REVERSIBLY. QTY 2: 2 PATIENTS DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK WHICH REQUIRED PACEMAKER INSERTION. QTY 1: 1 PATIENT WITH REDUCED LEFT VENTRICULAR EJECTION FRACTION AND LEFT BUNDLE BRANCH BLOCK UNDERWENT CARDIAC RESYNCHRONIZATION THERAPY DUE TO WORSENING HEART FAILURE. QTY 1: 1 PATIENT FOR PROGRESSIVE SYMPTOMATIC SINUS BRADYCARDIA WHICK REQUIRED PACEMAKER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404920 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTO3| UNK CIRCULAR MULTIELECTRODE CATHETER| UNK LONG SHEATH| UNK LONG SHEATH