BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24087524 · Received January 15, 2026

    Report

    Report Number
    2029046-2026-00191
    Event Type
    Injury
    Date Received
    January 15, 2026
    Report Date
    January 15, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. D4. CATALOG: UNK_SMART TOUCH BIDIRECTIONAL SF. THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: DE SMET MAJ, EL HADDAD M, DE BECKER B, FRANÇOIS C, AMIN R, TAVERNIER R, KNECHT S, DUYTSCHAEVER M, DE WAROUX JLP. RADIOFREQUENCY-AIDED VENOUS ETHANOL VS OPTIMIZED RADIOFREQUENCY FOR PRIMARY AND REPEAT ABLATION OF LEFT VENTRICULAR SUMMIT ARRHYTHMIAS: A PROPENSITY SCORE-MATCHED COMPARISON. HEART RHYTHM. 2025 NOV;22(11):2845-2856. DOI: 10.1016/J.HRTHM.2025.04.053. EPUB 2025 APR 30. PMID: 40315943. 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: DE SMET MAJ, EL HADDAD M, DE BECKER B, FRANÇOIS C, AMIN R, TAVERNIER R, KNECHT S, DUYTSCHAEVER M, DE WAROUX JLP. RADIOFREQUENCY-AIDED VENOUS ETHANOL VS OPTIMIZED RADIOFREQUENCY FOR PRIMARY AND REPEAT ABLATION OF LEFT VENTRICULAR SUMMIT ARRHYTHMIAS: A PROPENSITY SCORE-MATCHED COMPARISON. HEART RHYTHM. 2025 NOV;22(11):2845-2856. DOI: 10.1016/J.HRTHM.2025.04.053. EPUB 2025 APR 30. PMID: 40315943. BACKGROUND: RADIOFREQUENCY (RF) ABLATION OF LEFT VENTRICULAR SUMMIT ARRHYTHMIAS (LVSAS) IS CHALLENGING AND MAY FAIL DUE TO THE ANATOMICAL INACCESSIBILITY OF THE SUBSTRATE. CORONARY VENOUS ETHANOL ABLATION (CVEA) HAS BEEN SUGGESTED AS AN ALTERNATIVE ABLATION STRATEGY FOR DRUG- AND RF-REFRACTORY LVSA. OBJECTIVE: THIS STUDY COMPARED VENOUS ETHANOL WITH OR WITHOUT ADJUNCTIVE RF (CVEA ± RF) VS OPTIMIZED RF (ORF) FOR PRIMARY OR REPEAT ABLATION OF LVSA. METHODS: AFTER PROPENSITY SCORE MATCHING, 41 OF 43 PATIENTS TREATED WITH CVEA ± RF WERE COMPARED TO 41 OF 93 PATIENTS WHO UNDERWENT ORF ABLATION. CONCLUSION: WHEN VENOUS MAPPING SUPPORTS INTRAMURAL ORIGIN, RF-AIDED VENOUS ETHANOL ABLATION IS AN EFFECTIVE STRATEGY FOR THE TREATMENT OF LVSA ALSO WHEN COMPARED TO ORF ABLATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: AN IRRIGATED TIP AND CONTACT FORCE SENSING ABLATION CATHETER (BIOSENSE WEBSTER INC). OTHER BWI DEVICE(S): CARTO 3 MAPPING SYSTEM, DECAPOLAR CS CATHETER (BIOSENSE WEBSTER). NON-BWI DEVICE(S): LONG SHEATH (SL0, ABBOTT, SAINT PAUL, MN). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNKNOWN_BWI: ORF ABLATION WAS COMPLICATED BY: QTY 1: 1 TAMPONADE REQUIRING DRAINAGE QTY 1: 1 PATIENT DEVELOPED AN ACUTE CORONARY SYNDROME 1 DAY AFTER THE PROCEDURE. HE WAS KNOWN TO HAVE 3-VESSEL CORONARY ARTERY DISEASE AND REQUIRED A PERCUTANEOUS CORONARY INTERVENTION OF THE DISTAL LEFT ANTERIOR DESCENDING ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140551 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L BWI DECAPOLAR CS CATHETER.| CARTO 3 MAPPING SYSTEM.| LONG SHEATH SL0, ABBOTT.