BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SF NAV

    MDR report key: 24077755 · Received January 15, 2026

    Report

    Report Number
    2029046-2026-00181
    Event Type
    Injury
    Date Received
    January 15, 2026
    Report Date
    January 15, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: BRÜGGER J, ISENEGGER C, JORDAN F, SUBIN B, STUMP R, KNECHT S, SPREEN D, SCHAERLI N, KRISAI P, SCHAER B, MAHFOUD F, STICHERLING C, KÜHNE M, BADERTSCHER P. ANTERIOR MITRAL ISTHMUS LINE USING PULSED-FIELD ABLATION WITH THE PENTASPLINE CATHETER OR RADIOFREQUENCY ABLATION: PROCEDURAL CHARACTERISTICS, SAFETY, AND MID-TERM OUTCOMES. EUROPACE. 2025 OCT 31;27(11):EUAF265. DOI: 10.1093/EUROPACE/EUAF265. PMID: 41125244; PMCID: PMC12585187. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 AND THE FOLLOWING CITATION WAS REVIEWED: BRÜGGER J, ISENEGGER C, JORDAN F, SUBIN B, STUMP R, KNECHT S, SPREEN D, SCHAERLI N, KRISAI P, SCHAER B, MAHFOUD F, STICHERLING C, KÜHNE M, BADERTSCHER P. ANTERIOR MITRAL ISTHMUS LINE USING PULSED-FIELD ABLATION WITH THE PENTASPLINE CATHETER OR RADIOFREQUENCY ABLATION: PROCEDURAL CHARACTERISTICS, SAFETY, AND MID-TERM OUTCOMES. EUROPACE. 2025 OCT 31;27(11):EUAF265. DOI: 10.1093/EUROPACE/EUAF265. PMID: 41125244; PMCID: PMC12585187. BACKGROUND AND PURPOSE: PULSED-FIELD ABLATION (PFA) IS A NON-THERMAL ENERGY SOURCE FOR PULMONARY VEIN ISOLATION (PVI), OFFERING ADVANTAGES IN SAFETY AND PROCEDURAL EFFICIENCY. HOWEVER, DATA COMPARING ANTERIOR MITRAL ISTHMUS LINE (MIL) ABLATION USING PFA VS. CONVENTIONAL RADIOFREQUENCY ABLATION (RFA) ARE SCARCE. THIS STUDY AIMED TO COMPARE PROCEDURAL CHARACTERISTICS, SAFETY, AND ARRHYTHMIA RECURRENCE FOLLOWING PVI WITH ADDITIONAL ANTERIOR MIL ABLATION USING PFA VS. RFA. METHODS: IN THIS PROSPECTIVE, SINGLE-CENTRE ANALYSIS FROM THE SWISS-AF-PVI REGISTRY, 129 PATIENTS (MEDIAN AGE 70 YEARS, 40% FEMALE) UNDERGOING PVI WITH ANTERIOR MIL ABLATION WERE INCLUDED. PATIENTS RECEIVED EITHER PFA WITH A PENTASPLINE CATHETER (N = 61) OR RFA USING A 3.5 MM IRRIGATED TIP CATHETER (N = 68). PROCEDURAL PARAMETERS, COMPLICATIONS, AND ARRHYTHMIA RECURRENCE WERE ASSESSED OVER A MEDIAN FOLLOW-UP OF 327 DAYS. CONCLUSION: ANTERIOR MIL ABLATION USING PFA IS FEASIBLE, SAFE, AND MORE TIME-EFFICIENT THAN RFA, WITH COMPARABLE MID-TERM ARRHYTHMIA OUTCOMES. HOWEVER, HIGH RATES OF MIL RECONNECTION AND ARRHYTHMIA RECURRENCE HIGHLIGHTS THE NEED TO IMPROVE LESION DURABILITY. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SURROUND FLOW SF® ABLATION CATHETER. OTHER BWI DEVICE(S): CARTO3, MULTIPOLAR MAPPING CATHETER (OCTARAY). OTHER NON-BWI DEVICE(S): FARAPULSE PFA SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_THERMOCOOL SF NAV DEVICE(S): QTY: 2 PERICARDIAL TAMPONADES REQUIRE DRAINAGE IN THE RFA GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140875 THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L FARAPULSE SYSTEM| UNK_CARTO 3| UNK_OCTARAY NAV