BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24743746 · Received March 31, 2026

    Report

    Report Number
    2029046-2026-01040
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: F ZOU, S XU, S NAGRAJ, S MATHAI, A GIDON, NY WINT KYAW, JM, GIUSEPPE AMMIRATI, J MARAZZATO, A LIN, D Y YNOA, M SCHIAVONE, VM LA FAZIA, S MOHANTY, A NATALE, P SANTANGELI, X ZHANG, L D BIASE. ATRIAL FIBRILLATION ABLATION USING 3D ARTIFICIAL INTELLIGENCE MODULE INTEGRATION WITH INTRACARDIAC ECHOCARDIOGRAPHY. EP EUROPACE, VOLUME 28, ISSUE 2, FEBRUARY 2026, EUAG009, HTTPS://DOI.ORG/10.1093/EUROPACE/EUAG009 (CITATION ON PUBMED: NOT FOUND) D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: F ZOU, S XU, S NAGRAJ, S MATHAI, A GIDON, NY WINT KYAW, JM, GIUSEPPE AMMIRATI, J MARAZZATO, A LIN, D Y YNOA, M SCHIAVONE, VM LA FAZIA, S MOHANTY, A NATALE, P SANTANGELI, X ZHANG, L D BIASE. ATRIAL FIBRILLATION ABLATION USING 3D ARTIFICIAL INTELLIGENCE MODULE INTEGRATION WITH INTRACARDIAC ECHOCARDIOGRAPHY. EP EUROPACE, VOLUME 28, ISSUE 2, FEBRUARY 2026, EUAG009, HTTPS://DOI.ORG/10.1093/EUROPACE/EUAG009 (CITATION ON PUBMED: NOT FOUND) BACKGROUND AND PURPOSE: INTRACARDIAC ECHOCARDIOGRAPHY (ICE)-BASED ELECTROANATOMICAL MAPPING (EAM) IMPROVES PROCEDURAL EFFICIENCY AND SAFETY IN ATRIAL FIBRILLATION (AF) ABLATION AND REMAINS THE STANDARD OF CARE. THE CARTOSOUND FAM (AI FAM) MODULE USES A DEEP-LEARNING ALGORITHM THAT AUTOMATES LEFT ATRIAL RECONSTRUCTION WITHOUT MANUAL CONTOURING. THIS STUDY AIMS TO EVALUATE THE ONE-YEAR OUTCOMES OF AI FAM COMPARED TO STANDARD-OF-CARE EAM IN AF ABLATION. METHODS: THIS STUDY INCLUDED 298 PATIENTS UNDERGOING RADIOFREQUENCY AF ABLATION BETWEEN JAN 2021 TO DEC 2023. PATIENTS TREATED BEFORE JAN 2023 UNDERWENT STANDARD-OF-CARE EAM, WHILE THOSE IN 2023 UTILIZED AI FAM-BASED RECONSTRUCTION. BASELINE DEMOGRAPHICS, COMORBIDITIES, AF TYPE, AND MEDICATION USE WERE RECORDED. PROCEDURAL CHARACTERISTICS, ACUTE SUCCESS, COMPLICATIONS, AND AF RECURRENCE AT ONE-YEAR FOLLOW UP WERE ANALYZED. CONCLUSION: AI FAM WAS ASSOCIATED WITH INCREMENTAL BUT SIGNIFICANT PROCEDURAL ADVANTAGES OVER CONVENTIONAL CONTOURING VIA REDUCED TOTAL PROCEDURE TIME AND LA DWELL TIME, WITHOUT COMPROMISING ACUTE AND LONG-TERM SAFETY AND RHYTHM CONTROL EFFICACY. AI FAM INTEGRATION WITH PFA WILL MARK ANOTHER STEP TOWARDS MAKING AF ABLATION MORE STREAMLINED AND ACCESSIBLE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMACOOL SMARTTOUCH SF (STSF) CATHETER (BIOSENSE WEBSTER, IRVINE, CA) OTHER BWI DEVICE(S): INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER, CARTO 3 SYSTEM, CARTOSOUND FAM 1 RIGHT FEMORAL ARTERIOVENOUS FISTULA WAS REPORTED IN AI FAM GROUP, A VASCULAR COMPLICATION, THIS ADVERSE EVENT COULD BE ASSOCIATED WITH THE USE OF SHEATH; HOWEVER, THE SPECIFIC SHEATH MODEL WAS NOT SPECIFIED. CONVERSELY IN THE CONVENTIONAL EAM GROUP, 1 CEREBROVASCULAR ACCIDENT (CVA)/STROKE WAS OBSERVED AND WAS LIKELY RELATED TO AIR INTRODUCTION DURING SHEATH EXCHANGE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_THERMOCOOL SF NAV DEVICE(S): COMPLICATIONS OCCURRED IN EAM GROUP: QTY 1: 1 PERICARDIAL EFFUSION REQUIRING DRAINAGE. QTY 1: 1 LEFT ATRIAL (LA) PERFORATION REQUIRING SURGICAL REPAIR. QTY 1: 1 SINUS NODE DYSFUNCTION REQUIRING PERMANENT PACEMAKER IMPLANTATION FOR CONCURRENT ANTIARRHYTHMIC USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801507 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R