BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22949870 · Received September 3, 2025

    Report

    Report Number
    2029046-2025-02967
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    March 13, 2025
    Report Date
    September 3, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: XU R, DONG Y, YADAV N, CHEN Q, CAO K, ZHANG F. PREDICTION OF RECURRENCE OF ATRIAL FIBRILLATION AFTER RADIOFREQUENCY ABLATION BY FRAILTY. J AM HEART ASSOC. 2025 MAR 18;14(6):E038044. DOI: 10.1161/JAHA.124.038044. EPUB 2025 MAR 13. PMID: 40079343; PMCID: PMC12132767. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. 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: XU R, DONG Y, YADAV N, CHEN Q, CAO K, ZHANG F. PREDICTION OF RECURRENCE OF ATRIAL FIBRILLATION AFTER RADIOFREQUENCY ABLATION BY FRAILTY. J AM HEART ASSOC. 2025 MAR 18;14(6):E038044. DOI: 10.1161/JAHA.124.038044. EPUB 2025 MAR 13. PMID: 40079343; PMCID: PMC12132767. BACKGROUND: PREVIOUS STUDIES HAVE SHOWN THAT FRAILTY INCREASES THE RISK OF NEW-ONSET ATRIAL FIBRILLATION (AF). HOWEVER, LITTLE IS KNOWN ABOUT THE ASSOCIATION BETWEEN FRAILTY AND THE RECURRENCE OF AF AFTER RADIOFREQUENCY ABLATION. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE ASSOCIATION BETWEEN FRAILTY AND THE RECURRENCE IN PATIENTS WITH AF WHO HAD UNDERGONE RADIOFREQUENCY ABLATION. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE RELATIONSHIP BETWEEN FRAILTY AND RECURRENCE IN PATIENTS WITH AF WHO HAD UNDERGONE RADIOFREQUENCY ABLATION. METHODS: A TOTAL OF 450 PATIENTS >50 YEARS OF AGE WITH SYMPTOMATIC DRUG-REFRACTORY AF WHO HAD UNDERGONE CATHETER ABLATION FOR THE FIRST TIME WERE RETROSPECTIVELY ENROLLED. FRAILTY STATUS WAS EVALUATED BY THE 11-FACTOR MODIFIED FRAILTY INDEX AND 5-FACTOR MODIFIED FRAILTY INDEX. RECURRENCE WAS DEFINED AS ANY DOCUMENTED ATRIAL TACHYARRHYTHMIA LASTING >30 SECONDS AFTER A 3-MONTH BLANKING PERIOD WITHOUT ANY ANTIARRHYTHMIC DRUGS DURING POSTABLATION FOLLOW-UP. PATIENTS IN THE FRAIL GROUP WERE OLDER, AND HAD A HIGHER CHA2DS2-VASC SCORE, HAS-BLED SCORE, LEFT ATRIAL DIAMETER, AND A HIGHER PROPORTION OF COMORBIDITIES THAN THOSE IN THE NONFRAIL GROUP. CIRCUMFERENTIAL PULMONARY VEIN ISOLATION WAS SUCCESSFULLY DONE IN ALL OF THE PATIENTS. DURING A MEDIAN FOLLOW-UP OF 12 MONTHS, RECURRENCE WAS RECORDED IN 98 (21.8%) PATIENTS (PAROXYSMAL AF, 20.6%; PERSISTENT AF, 23.2%). THE KAPLAN-MEIER ANALYSIS SHOWED THAT THE SURVIVAL RATE OF FREEDOM FROM ATRIAL TACHYARRHYTHMIAS IN THE FRAIL GROUP WAS LOWER THAN THAT IN NONFRAIL GROUPS (LOG-RANK P<0.001, 11-FACTOR MODIFIED FRAILTY INDEX 31.3% VERSUS 82.4%, 5-FACTOR MODIFIED FRAILTY INDEX 44.9% VERSUS 87.5%). AFTER ADJUSTMENT OF ADDITIONAL RISK FACTORS IN MULTIVARIABLE COX ANALYSIS, 11-FACTOR MODIFIED FRAILTY INDEX (HAZARD RATIO [HR], 5.72 [95% CI, 3.79¿8.64]; P<0.001) OR 5-FACTOR MODIFIED FRAILTY INDEX (HR, 5.62 [95% CI, 3.68¿8.59]; P<0.001) WAS SIGNIFICANTLY ASSOCIATED WITH ATRIAL TACHYARRHYTHMIA RECURRENCE. THE RESULTS REMAIN SIGNIFICANT IN THE SUBGROUP ANALYSES OF DIFFERENT AF TYPES, AGE GROUPS, AND SEX. NO SIGNIFICANT DIFFERENCES OF MAJOR COMPLICATIONS WERE OBSERVED BETWEEN THE FRAIL AND NONFRAIL GROUPS. CONCLUSIONS: IN PATIENTS WITH AF WHO HAD UNDERGONE CATHETER ABLATION, FRAIL PATIENTS HAD AROUND A 6-FOLD RISK OF RECURRENCE AS COMPARED WITH THE NONFRAIL PATIENTS. FRAILTY INDEX MAY BE A NOVEL RISK FACTOR OF RECURRENT AF. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: OPEN-IRRIGATED ABLATION CATHETER (THERMOCOOL SMARTTOUCH; BIOSENSE WEBSTER, DIAMOND BAR, CA). OTHER BWI PRODUCTS: (CARTO3; BIOSENSE WEBSTER). NON-BWI DEVICES: UNKNOWN MANUFACTURER 6F DECAPOLAR CATHETER AND A 6F QUADRIPOLAR CATHETER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1:1 CASE OF PERICARDIAL TAMPONADE (MAJOR COMPLICATION). THE PATIENT SUCCESSFULLY UNDERWENT THORACOTOMY AND WAS DISCHARGED AFTER PROPER MANAGEMENT AND RECOVERY. QTY 2: 2 CASES OF STROKE (MAJOR COMPLICATIONS). NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386342 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening UNK_6F DECAPOLAR CATHETER| UNK_6F QUADRIPOLAR CATHETER| UNK_SMART TOUCH UNIDIRECTIONAL SF