BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 23248301 · Received October 8, 2025

    Report

    Report Number
    2029046-2025-03400
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 8, 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

    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: ZHAO D, DONG Y, CHEN Q, GE G, YADAV N, YANG D, ZHANG F. THE IMPACT OF LEFT ATRIAL VOLTAGE ABNORMALITY ON ABLATION OUTCOMES IN PAROXYSMAL ATRIAL FIBRILLATION AND ITS PRE-PROCEDURAL PREDICTORS: AN OBSERVATIONAL RETROSPECTIVE STUDY. EGYPT HEART J. 2025 JUL 31;77(1):77. DOI: 10.1186/S43044-025-00664-W. PMID: 40745129; PMCID: PMC12314127. 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: ZHAO D, DONG Y, CHEN Q, GE G, YADAV N, YANG D, ZHANG F. THE IMPACT OF LEFT ATRIAL VOLTAGE ABNORMALITY ON ABLATION OUTCOMES IN PAROXYSMAL ATRIAL FIBRILLATION AND ITS PRE-PROCEDURAL PREDICTORS: AN OBSERVATIONAL RETROSPECTIVE STUDY. EGYPT HEART J. 2025 JUL 31;77(1):77. DOI: 10.1186/S43044-025-00664-W. PMID: 40745129; PMCID: PMC12314127. BACKGROUND: LEFT ATRIAL (LA) LOCALIZED VOLTAGE ABNORMALITY DISPLAYED BY ELECTRO-ANATOMIC MAPPING (EAM) HAS BEEN ESTABLISHED AS A SURROGATE MARKER OF ATRIAL FIBROSIS (AF) WHICH PREDICTS POST-ABLATION RECURRENCE. THIS STUDY INVESTIGATES PREOPERATIVE PREDICTORS OF LA VOLTAGE ABNORMALITIES AND ASSESSES THEIR IMPACT ON ATRIAL FIBRILLATION RECURRENCE FOLLOWING CATHETER ABLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF). OBJECTIVE: WE AIMED TO INVESTIGATE THE IMPACT OF LA VOLTAGE ABNORMALITY ON ABLATION OUTCOMES IN PAF PATIENTS AND ITS PRE-PROCEDURAL PREDICTORS INCLUDING THE ATA BURDEN. METHODS: THIS IS A SINGLE-CENTER RETROSPECTIVE OBSERVATIONAL COHORT STUDY CONDUCTED BETWEEN JANUARY 2020 AND OCTOBER 2022 AT THE FIRST AFFILIATED HOSPITAL OF NANJING MEDICAL UNIVERSITY IN NANJING, CHINA. A TOTAL OF 172 CONSECUTIVE PATIENTS WITH SYMPTOMATIC, DRUG-REFRACTORY PAF, WHO UNDERWENT HIGH-DENSITY LA EAM BEFORE ABLATION, WERE ENROLLED IN THIS STUDY. PATIENTS WITH A LA MAPPING NUMBER OF<1000 POINTS, SIGNIFICANT STRUCTURAL HEART DISEASE (SHD), LEFT VENTRICULAR EJECTION FRACTION (LVEF)<40%, PREVIOUS MYOCARDIAL INFARCTION, SEVERE RENAL IMPAIRMENT (INCLUDING DIALYSIS), PREVIOUS AF ABLATION, AND PATIENTS WHO HAD UNDERGONE OPEN HEART SURGERY WERE EXCLUDED FROM THIS STUDY. ATA BURDEN AT BASELINE WAS DEFINED AS THE PERCENTAGE OF MONITORING TIME SPENT IN ATA [TOTAL NUMBER OF HOURS SPENT IN AF, ATRIAL TACHYCARDIA (AT), OR ATRIAL FLUTTER (AFL) SUSTAINING=30 S/TOTAL NUMBER OF RECORDING HOURS]. WE COLLECTED THE ATA BURDEN FROM THE HOLTER PERFORMED IN THE 1 WEEK BEFORE ABLATION AND IN THE ABSENCE OF ANTIARRHYTHMIC MEDICATION. CONCLUSIONS: LA VOLTAGE ABNORMALITY, EVEN MODERATE, IS INDEPENDENTLY RELATED TO POST-ABLATION RECURRENCE IN PAF PATIENTS. IT CAN BE PREDICTED PRE-PROCEDURE BY LA DILATION (LAD=37 MM) AND HIGH ATA BURDEN (=37.6%). LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH THE REPORTED DEVICE RELATED ISSUES: (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER, DIAMOND BAR, CA). OTHER BWI PRODUCTS: THREE-DIMENSIONAL EAM SYSTEM (CARTO 3, V6.0 BIOSENSE WEBSTER, DIAMOND BAR, USA), A MAPPING CATHETER (PENTARAY, BIOSENSE WEBSTER, DIAMOND BAR, CA). DEVICE RELATED ISSUE(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY (B)(4): 16 PATIENTS DEVELOPED CORONARY HEART DISEASE TREATED WITH ACEI/ARB: ANGIOTENSIN-CONVERTING ENZYME INHIBITORS/ANGIOTENSIN RECEPTOR BLOCKERS; CCB: CALCIUM CHANNEL BLOCKERS. QTY 6: 6 PATIENTS HAD STROKE. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616690 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other UNK_CARTO 3| UNK_PENTARAY