BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR THERMOCOOL

    MDR report key: 23689506 · Received December 1, 2025

    Report

    Report Number
    2029046-2025-03962
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    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 ARTICLE HAS BEEN REVIEWED: XIAO-YING L, DE-YONG L, JIAN-ZENG D, XIN D, CAI-HUA S, RONG-H, CHEN-XI J, NIAN L, SONG-NAN L, WEI W, XUE-YUAN G, XIN Z, CHANG-YI L, SONG Z, MENG-MENG L, CHANG-QI J, YUE-XIN J, WEN-HE L, ZE-YANG W, YU-KUN L, XUE-SI W, ZHUO-HANG D, RI-BO T & CHANG-SHENG M. SAFETY AND EFFECTIVENESS OF CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH MITRAL VALVE REPLACEMENT MECHANICAL VERSUS BIOPROSTHETIC VALVES. DEPARTMENT OF CARDIOLOGY, BEIJING ANZHEN HOSPITAL. DOI: HTTPS://DOI.ORG/10.1038/S41598-025-06592-8. 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 ARTICLE HAS BEEN REVIEWED: XIAO-YING L, DE-YONG L, JIAN-ZENG D, XIN D, CAI-HUA S, RONG-H, CHEN-XI J, NIAN L, SONG-NAN L, WEI W, XUE-YUAN G, XIN Z, CHANG-YI L, SONG Z, MENG-MENG L, CHANG-QI J, YUE-XIN J, WEN-HE L, ZE-YANG W, YU-KUN L, XUE-SI W, ZHUO-HANG D, RI-BO T & CHANG-SHENG M. SAFETY AND EFFECTIVENESS OF CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS WITH MITRAL VALVE REPLACEMENT MECHANICAL VERSUS BIOPROSTHETIC VALVES. DEPARTMENT OF CARDIOLOGY, BEIJING ANZHEN HOSPITAL. DOI: HTTPS://DOI.ORG/10.1038/S41598-025-06592-8. BACKGROUND: ATRIAL FIBRILLATION (AF) IS THE MOST COMMON SUSTAINED ARRHYTHMIA, AFFECTING 2¿4% OF ADULTS1 . MITRAL VALVE DISEASES ARE STRONGLY ASSOCIATED WITH AF DEVELOPMENT, WITH 30¿40% OF PATIENTS WITH RHEUMATIC MITRAL VALVE DISEASE EXPERIENCING AF2¿4 . LONG-TERM FOLLOW-UP REVEALS THAT 41¿47% OF PATIENTS WITH MITRAL VALVE DISEASE DEVELOPED AF5 . MITRAL VALVE DISEASES MAY CONTRIBUTE TO THE OCCURRENCE OF AF BY CAUSING VOLUME OVERLOAD AND LEFT ATRIAL ENLARGEMENT6 . THE HIGH PREVALENCE OF PERSISTENT AF CONTINUES EVEN AFTER MITRAL VALVE SURGERY CORRECTED HEMODYNAMIC ABNORMALITIES, AS SEEN IN PREVIOUS STUDY7 . PROSTHETIC VALVE REPLACEMENT IS A PRIMARY SURGICAL INTERVENTION FOR MITRAL VALVE DISEASE, WITH OPTIONS INCLUDING MECHANICAL AND BIOPROSTHETIC MITRAL VALVES. MECHANICAL VALVES OFFER LONG-TERM DURABILITY. HOWEVER, LIFELONG WARFARIN ANTICOAGULATION IS REQUIRED IN THE PATIENTS WITH MECHANICAL MITRAL VALVE REPLACEMENT (MVR). IN CONTRAST, BIOPROSTHETIC MVR DO NOT REQUIRE LONG-TERM ANTICOAGULATION. HOWEVER, IT IS PRONE TO HAVE STRUCTURAL VALVE DETERIORATION AND HAVE A HIGHER RISK OF REOPERATION IN THE PATIENTS WITH BIOPROSTHETIC MVR8 . CATHETER ABLATION HAS BEEN ESTABLISHED AS AN EFFECTIVE TREATMENT FOR AF, WITH EVIDENCE SUPPORTING ITS SAFETY AND EFFECTIVENESS IN PATIENTS WITH MECHANICAL MVR9 . HOWEVER, THERE WAS A PAUCITY OF DATA ON THE IMPACT OF CATHETER ABLATION OF AF IN PATIENTS WITH BIOPROSTHETIC MVR. OBJECTIVES: THIS STUDY AIMS TO INVESTIGATE WHETHER THERE IS A DIFFERENCE IN THE SAFETY AND EFFICACY OF CATHETER ABLATION OF AF IN PATIENTS WITH BIOPROSTHETIC MVR VERSUS THOSE WITH MECHANICAL MVR. METHODS: A TOTAL OF 23,794 PATIENTS WHO UNDERWENT THE FIRST-TIME CATHETER ABLATION OF AF IN BEIJING ANZHEN HOSPITAL FROM JANUARY 2015 TO JUNE 2023 WERE SCREENED. PATIENTS AGED 18 YEARS OR OLDER WITH A DIAGNOSIS OF AF AND A HISTORY OF MVR WERE INCLUDED. PATIENTS WERE EXCLUDED IF THEY HAD A HISTORY OF CATHETER ABLATION, SURGICAL AF ABLATION, LEFT ATRIAL APPENDAGE CLOSURE OR RESECTION. OF THE 23,794 PATIENTS, 351 HAD UNDERGONE MVR. AMONG THESE, 130 HAD SURGICAL AF ABLATION DURING VALVE REPLACEMENT, 112 PATIENTS HAD PREVIOUS CATHETER ABLATION OR LEFT ATRIAL APPENDAGE CLOSURE OR RESECTION, AND 3 DECLINED FOLLOW-UP. FINALLY, 106 PATIENTS WERE ENROLLED IN THE STUDY. AMONG THEM 21 PATIENTS WERE ENROLLED IN THE BIOPROSTHETIC MVR GROUP AND 85 PATIENTS IN THE MECHANICAL MVR GROUP. INFORM CONSENTS WERE OBTAINED FROM ALL PATIENTS PRIOR TO THE ABLATION PROCEDURE. THIS STUDY WAS APPROVED AND SUPERVISED BY THE ETHICS COMMITTEE OF BEIJING ANZHEN HOSPITAL AND ALL METHODS WERE CARRIED OUT IN ACCORDANCE WITH RELEVANT GUIDELINES AND REGULATIONS CONCLUSIONS: IN CONCLUSION, THIS STUDY DEMONSTRATED THE RATE OF AF RECURRENCE AFTER CATHETER ABLATION WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE PATIENTS WITH BIOPROSTHETIC MVR AND MECHANICAL MVR. THE SAFETY AND EFFECTIVENESS OF CATHETER ABLATION OF AF WERE COMPARABLE BETWEEN THE PATIENTS WITH MECHANICAL MVR AND BIOPROSTHETIC MVR. BUT LOWER INCIDENCE OF PROCEDURE-RELATED COMPLICATION WAS REPORTED IN THE PATIENTS WITH BIOPROSTHETIC MVR. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVI-STAR THERMOCOOL SMARTTOUCH® CATHETER OR NAVI-STAR THERMOCOOL SMARTTOUCH SF® CATHETER (BIOSENSE-WEBSTER, USA). OTHER BWI PRODUCTS: CARTO 3, PENTRAY NAV ECO TIP CATHETER (BIOSENES WEBSTER, USA) NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 CASE OF ACUTE CEREBRAL INFARCTION ON THE FIRST POSTOPERATIVE DAY, WITH AN INTERNATIONAL NORMALIZED RATIO (INR) OF 2.77. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850934 NAVISTAR THERMOCOOL CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARTO 3| PENTARAY NAV ECO