BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 24070340 · Received January 14, 2026

    Report

    Report Number
    2029046-2026-00154
    Event Type
    Injury
    Date Received
    January 14, 2026
    Report Date
    January 14, 2026
    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

    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: LIN W, CHU H, WANG C, CHANG D, YIN X, WANG Y, JIANG C, XU Y, LIAO Q, YANG J, ZHU W, LI S, GAO W, CHEN Y, YU Y, LI Q, LIAO H, DENG H, WEI W, PU S, GUO Z, XU D, LI W, OUYANG F, XUE Y; INSIGHTPFA INVESTIGATORS. PULSED FIELD ABLATION USING A NOVEL BIPHASIC CATHETER VS THERMAL ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: INSIGHTPFA TRIAL. J AM COLL CARDIOL. 2025 DEC 9;86(23):2314-2326. DOI: 10.1016/J.JACC.2025.09.1593. PMID: 41338842. PC-002051863. 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 THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LIN W, CHU H, WANG C, CHANG D, YIN X, WANG Y, JIANG C, XU Y, LIAO Q, YANG J, ZHU W, LI S, GAO W, CHEN Y, YU Y, LI Q, LIAO H, DENG H, WEI W, PU S, GUO Z, XU D, LI W, OUYANG F, XUE Y; INSIGHTPFA INVESTIGATORS. PULSED FIELD ABLATION USING A NOVEL BIPHASIC CATHETER VS THERMAL ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: INSIGHTPFA TRIAL. J AM COLL CARDIOL. 2025 DEC 9;86(23):2314-2326. DOI: 10.1016/J.JACC.2025.09.1593. PMID: 41338842. BACKGROUND: THE CLINICAL PERFORMANCE OF A NOVEL NANOSECOND PULSED FIELD ABLATION (NSPFA) SYSTEM (INSIGHT MEDTECH) FOR PULMONARY VEIN ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION REMAINS UNCLEAR. OBJECTIVES: THIS TRIAL SOUGHT TO EVALUATE THE EFFICACY AND SAFETY OF NSPFA VS ABLATION INDEX (AI)¿GUIDED RADIOFREQUENCY ABLATION (RFA) FOR SYMPTOMATIC ATRIAL FIBRILLATION. METHODS: THE INSIGHTPFA TRIAL WAS A PROSPECTIVE, MULTICENTER, RANDOMIZED CONTROLLED TRIAL. PATIENTS WERE RANDOMLY ALLOCATED IN A 1:1 RATIO TO RECEIVE EITHER NSPFA OR ABLATION INDEX (AI)¿GUIDED RFA FOR PULMONARY VEIN ISOLATION. PARTICI PANTS COMPLETED A STANDARDIZED 12-MONTH FOLLOW-UP PROTOCOL. THE PRIMARY EFFICACY ENDPOINT WAS DEFINED AS FREEDOM FROM DOCUMENTED ATRIAL TACHYARRHYTHMIA RECURRENCE WITHOUT THE USE OF CLASS I OR III ANTIARRHYTHMIC DRUGS. THE SAFETY ASSESSMENT EVALUATED DEATH, STROKE, TRANSIENT ISCHEMIC ATTACK, PROCEDURE-AND DEVICE-RELATED EVENTS, AND OTHER ADVERSE OUTCOMES IN BOTH GROUPS. SECONDARY EFFICACY ENDPOINTS INCLUDED ACUTE PROCEDURAL SUCCESS AND PROCEDURAL EVALUATIONS. CONCLUSIONS: THE NSPFA EXHIBITED NONINFERIOR EFFICACY AND COMPARABLE SAFETY TO AI-GUIDED RFA WHILE OBVIATING THE NEED FOR GENERAL ANESTHESIA. FURTHERMORE, THE STUDY REVEALED THAT THIS ABLATION TECHNIQUE SIGNIFICANTLY REDUCED BOTH TOTAL PROCEDURE TIME AND LEFT ATRIAL DWELLING TIME. (INSIGHTPFA TRIAL OF THE LOTOSPFA CATHETER [INSIGHTPFA]; NCT06014996) (JACC. 2025;86:2314¿2326) © 2025 THE AUTHORS. PUBLISHED BY ELSEVIER ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 7.5-F THERMOCOOL SMARTTOUCH CATHETER (BIOSENSE WEBSTER). OTHER BWI PRODUCTS: CORDIS 0.035 × 260 CM GUIDEWIRE (JOHNSON & JOHNSON), PEN TARAY (BIOSENSE WEBSTER), LASSO (BIOSENSE WEBSTER), CARTO SYSTEM (BIOSENSE WEBSTER). NON-BWI DEVICES: 12-F INBRIDGE STEERABLE SHEATH (INSIGHT MEDTECH), LOTOSPFA PFA CATHETER (INSIGHT MEDTECH), INRYTHM SYSTEM. 1 PATIENT DEVELOPED A TRANSIENT ST SEGMENT ELEVATION LIKELY DUE TO AIR EMBOLISM. THIS ADVERSE EVENT COULD BE ASSOCIATED WITH THE USE OF LOTOSPFA PFA CATHETER (INSIGHT MEDTECH). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 CASE OF MILD LEFT INFERIOR PV STENOSIS. NO INTERVENTION MENTIONED. QTY 1: 1 CASE OF CHEST PAIN. NO INTERVENTION MENTIONED. QTY 1: 1 CASE OF ESOPHAGEAL INJURY. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128266 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening 12-F INBRIDGE STEERABLE SHEATH.| CARTO 3.| CORDIS 0.035 × 260 CM GUIDEWIRE.| INRYTHM SYSTEM.| LASSO.| LOTOSPFA PFA CATHETER.| PENTARAY.