BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR RMT THERMOCOOL

    MDR report key: 22924136 · Received August 29, 2025

    Report

    Report Number
    2029046-2025-02928
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 24, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 04-SEP-2025, NOTED A CORRECTION TO THE 3500A INITIAL UNDER THE H6. COMPONENT CODE AS IT WAS PROCESSED AS "APPROPRIATE TERM / CODE NOT AVAILABLE (G07002)" AND SHOULD HAVE BEEN PROCESSED AS "INSUFFICIENT INFORMATION (G07003)". THEREFORE, CORRECTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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: LIU Z, LI X, WEI Y, LI X, LUO Q, XIE Y, LIN C, HAN Y, YU Y, ZHANG N, LING T, CHEN K, PAN W, BAO Y, WU L, JIN Q. IMPROVED PROCEDURAL EFFICIENCY OF ATRIAL FIBRILLATION ABLATION USING ROBOTIC MAGNETIC NAVIGATION. HEART RHYTHM O2. 2025 MAY 11;6(7):920-927. DOI: 10.1016/J.HROO.2025.05.003. PMID: 40734742; PMCID: PMC12302197. 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: LIU Z, LI X, WEI Y, LI X, LUO Q, XIE Y, LIN C, HAN Y, YU Y, ZHANG N, LING T, CHEN K, PAN W, BAO Y, WU L, JIN Q. IMPROVED PROCEDURAL EFFICIENCY OF ATRIAL FIBRILLATION ABLATION USING ROBOTIC MAGNETIC NAVIGATION. HEART RHYTHM O2. 2025 MAY 11;6(7):920-927. DOI: 10.1016/J.HROO.2025.05.003. PMID: 40734742; PMCID: PMC12302197. BACKGROUND: CURRENTLY, THERE IS STILL A LARGE VARIABILITY IN PROCEDURAL EFFICIENCY OF ATRIAL FIBRILLATION (AF) ABLATION. OBJECTIVE: THIS STUDY AIMED TO EVALUATE THE EVOLUTION OF PROCEDURAL EFFICIENCY OF AF ABLATION USING ROBOTIC MAGNETIC NAVIGATION (RMN) AND COMPARE THE MOST EFFICIENT APPROACH WITH CRYOBALLOON ABLATION (CRYO), A TYPICAL ¿SINGLE-SHOT¿ TECHNIQUE. METHODS: A TOTAL OF 2028 AF ABLATION PROCEDURES WITH RMN WERE CONSECUTIVELY INCLUDED AND DIVIDED INTO 3 GROUPS BASED ON ABLATION TECHNIQUE EVOLUTION (GROUP 1, ABLATION CATHETER WITH FIXED SHEATH, STANDARD-POWER, LONG-DURATION, N 5 523; GROUP 2, STEERABLE SHEATH, STANDARD-POWER, LONG-DURATION, N 5 994; AND GROUP 3, STEERABLE SHEATH, HIGH-POWER, SHORT-DURATION, N 5 511). FOR COMPARISON, PATIENTS TREATED WITH THE MOST EFFICIENT ABLATION STRATEGY WITH RMN (N 5 85) OR CRYO (N 5 85) WERE MATCHED USING A 1:1 PROPENSITY SCORE AND ANALYZED WITHIN THE SAME PERIOD. CONCLUSIONS: THE PROCEDURAL EFFICIENCY OF RMN-GUIDED AF ABLATION HAS BEEN REMARKABLY IMPROVED WITH STEERABLE SHEATH AND HIGH POWER, SHORT-DURATION ABLATION. THIS TECHNIQUE IS GENERALLY EQUIVALENT TO CRYO WITH REGARD TO PROCEDURE TIME AND OVERALL EFFICACY. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING A 3.5 MM TIP IRRIGATED MAGNETIC CATHETER (NAVISTAR RMT THERMOCOOL, BIOSENSE WEBSTER INC). OTHER BWI PRODUCTS: A CIRCULAR CATHETER (LASSO, BIOSENSE WEBSTER INC, DIAMOND BAR, CA) OR 22-POLE HIGH-DENSITY MAPPING CATHETER (PENTARAY, BIOSENSE WEBSTER INC), STEERABLE SHEATH (MOBICATH OR VIZIGO, BIOSENSE WEBSTER INC). NON-BWI DEVICES: A STANDARD FIXED-CURVE LONG SHEATH (FAST-CATH SR0 OR SL1, ST. JUDE MEDICAL INC) AND A SECOND-GENERATION CRYOBALLOON (ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER, MEDTRONIC). TRANSIENT PHRENIC NERVE PARALYSIS APPEARED IN 2 PATIENTS. THIS WILL NOT BE CAPTURED SINCE THIS WAS HAPPENED AFTER THE CRYOBALLOON PROCEDURE. THIS WAS NOT RELATED TO THE BWI DEVICES SPECIFICALLY FOR THERMOCOOL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 3: 3 REPORTED MAJOR COMPLICATIONS FOR CARDIAC TAMPONADE. NO INTERVENTION MENTIONED. QTY 2: 2 REPORTED MAJOR COMPLICATIONS FOR STROKE/TIA. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221692 NAVISTAR RMT 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 BWI STEERABLE SHEATH.| MEDTRONIC CRYOABLATION CATHETER.| ST. JUDE STANDARD FIXED-CURVE LONG SHEATH.| UNK_LASSO.| UNK_PENTARAY.