BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF NON NAV

    MDR report key: 23692682 · Received December 2, 2025

    Report

    Report Number
    2029046-2025-03966
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    September 12, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO. (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG Y, LUO C, FENG M, YU Y, DU X, SHEN C, FU G, WANG B, FANG R, JIN H, GAO F, CHU H. HIGHER PREMATURE ATRIAL CONTRACTION BURDEN AFTER RADIOFREQUENCY ABLATION VS. PULSED FIELD OR CRYOBALLOON ABLATION IN PAROXYSMAL ATRIAL FIBRILLATION: A 3-YEAR FOLLOW-UP RETROSPECTIVE STUDY. FRONT CARDIOVASC MED. 2025 SEP 12;12:1627579. DOI: 10.3389/FCVM.2025.1627579. PMID: 41019430; PMCID: PMC12463900. 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: 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG Y, LUO C, FENG M, YU Y, DU X, SHEN C, FU G, WANG B, FANG R, JIN H, GAO F, CHU H. HIGHER PREMATURE ATRIAL CONTRACTION BURDEN AFTER RADIOFREQUENCY ABLATION VS. PULSED FIELD OR CRYOBALLOON ABLATION IN PAROXYSMAL ATRIAL FIBRILLATION: A 3-YEAR FOLLOW-UP RETROSPECTIVE STUDY. FRONT CARDIOVASC MED. 2025 SEP 12;12:1627579. DOI: 10.3389/FCVM.2025.1627579. PMID: 41019430; PMCID: PMC12463900. BACKGROUND: PULSED FIELD ABLATION (PFA), A NOVEL NON-THERMAL ENERGY SOURCE, HAS SHOWN FAVORABLE 1-YEAR DATA ON THE EFFICACY AND SAFETY PROFILE IN THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION (PAF). WE SOUGHT TO COMPARE PFA, CRYOBALLOON ABLATION (CBA), AND RADIOFREQUENCY ABLATION (RFA) IN PAF TREATMENT IN A 3-YEAR FOLLOW-UP PERIOD. METHODS: PATIENTS WITH PAF UNDERGOING FIRST-TIME CATHETER ABLATION BY PFA, CBA, AND RFA WERE RETROSPECTIVELY INCLUDED. THE PROCEDURE ENDPOINT WAS PULMONARY VEIN ISOLATION (PVI). PATIENTS WERE FOLLOWED WITH 24 H AMBULATORY ECG MONITORING AT 1, 3, 6, AND 12 MONTHS AND EVERY 6 MONTHS THEREAFTER. THE PRIMARY EFFICACY ENDPOINT WAS FREEDOM FROM ANY ATRIAL TACHYARRHYTHMIA >30 S OCCURRING AFTER THE 3-MONTH BLANKING PERIOD. CONCLUSIONS: AT THE 3-YEAR FOLLOW-UP, ARRHYTHMIA FREEDOM WAS SIMILAR IN PFA, CBA, AND RFA IN PATIENTS WITH PAF. PFA AND CBA CONTRIBUTED TO SIGNIFICANTLY LOWER PAC BURDEN COMPARED WITH RFA IN PATIENTS WITHOUT RECURRENCE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SURROUND FLOW. OTHER BWI PRODUCTS: STEERABLE SHEATH (VIZIGO, BIOSENSE WEBSTER, CA, USA) ,3D ELECTROANATOMICAL MAPPING SYSTEM (CARTO 3, BIOSENSE WEBSTER, CA, USA) AND MULTIPOLAR CATHETER (PENTARAY, BIOSENSE WEBSTER, CA, USA). NON-BWI DEVICES: FIXED SHEATH (SL1, ABBOTT, SAINT PAUL, MN, USA), FOURTH-GENERATION CRYOBALLOON (ARTFREEZERTM, ARTECHMED, SHANGHAI, CHINA) AND CARDIPULSETM PFA SYSTEM (HANGZHOU DINOVA EP TECHNOLOGY CO., LTD, CHINA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_THERMOCOOL SF NON NAV DEVICES: QTY 1: 1 PATIENT IN THE RFA GROUP DEVELOPED A PERICARDIAL EFFUSION ON THE DAY OF ABLATION, WHICH WAS RESOLVED WITH PERCUTANEOUS DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783267 THERMOCOOL SF NON NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R 3D ELECTROANATOMICAL MAPPING SYSTEM| CARDIPULSETM PFA SYSTEM| FIXED SHEATH| FOURTH-GENERATION CRYOBALLOON| MULTIPOLAR CATHETER| STEERABLE SHEATH