BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23689297 · Received December 1, 2025

    Report

    Report Number
    2029046-2025-03959
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    July 4, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG Y, LONG D, XIAO F, CHEN M, LIU X, ZHANG J, XUE Y, FAN J, WANG H, WU M, WANG R, LI J, HE T, GE W, HUANG X, JIANG R, LIU Q, ZHANG Z, FU G, JIANG C. MULTICENTER PRACTICE OF NON/MINIMIZED FLUOROSCOPY ABLATION FOR PAROXYSMAL AF IN CHINA: THE PAF-ICE TRIAL. JACC ASIA. 2025 AUG 29:S2772-3747(25)00384-9. DOI: 10.1016/J.JACASI.2025.07.011. EPUB AHEAD OF PRINT. PMID: 40910962. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG Y, LONG D, XIAO F, CHEN M, LIU X, ZHANG J, XUE Y, FAN J, WANG H, WU M, WANG R, LI J, HE T, GE W, HUANG X, JIANG R, LIU Q, ZHANG Z, FU G, JIANG C. MULTICENTER PRACTICE OF NON/MINIMIZED FLUOROSCOPY ABLATION FOR PAROXYSMAL AF IN CHINA: THE PAF-ICE TRIAL. JACC ASIA. 2025 AUG 29:S2772-3747(25)00384-9. DOI: 10.1016/J.JACASI.2025.07.011. EPUB AHEAD OF PRINT. PMID: 40910962. BACKGROUND: INTRACARDIAC ECHOCARDIOGRAPHY (ICE)-GUIDED NON/MINIMIZED-FLUOROSCOPY CATHETER ABLATION FOR ATRIAL FIBRILLATION (AF) HAS BEEN REPORTED, BUT ITS EFFECTIVENESS AND SAFETY STILL LACK MULTICENTER EVIDENCE. OBJECTIVES: THE AUTHORS SOUGHT TO EVALUATE THE EFFECTIVENESS AND SAFETY OF ICE-GUIDED NON/MINIMIZED-FLUOROSCOPY CATHETER ABLATION COMPARED WITH THE TRADITIONAL FLUOROSCOPY-GUIDED APPROACH IN PATIENTS WITH PAROXYSMAL AF. METHODS: A TOTAL OF 448 PATIENTS WITH PAROXYSMAL AF, FROM 15 CENTERS IN CHINA, WERE RANDOMLY ASSIGNED IN A 1:1 RATIO TO A NON/MINIMIZED-FLUOROSCOPY GROUP (N = 223) AND A TRADITIONAL APPROACH GROUP (N = 225). THE PRIMARY EFFICACY ENDPOINT WAS FREEDOM FROM AF RECURRENCE AFTER A SINGLE ABLATION PROCEDURE. THE PRIMARY SAFETY ENDPOINT WAS A COMPOSITE OF DEATH FROM ANY CAUSE, STROKE OR TRANSIENT ISCHEMIC ATTACK, AND OTHER SERIOUS ADVERSE EVENTS. CONCLUSIONS: ICE-COMBINED NON/MINIMIZED-FLUOROSCOPY AF ABLATION WAS NONINFERIOR IN EFFECTIVENESS COMPARED TO TRADITIONAL AF ABLATION, WITH NO SIGNIFICANT DIFFERENCE IN SAFETY ENDPOINTS, INDICATING ITS POTENTIAL OF WIDESPREAD ADOPTION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH SURROUND FLOW OR SMARTTOUCH ABLATION CATHETER AND SOUNDSTAR CATHETER OTHER BWI DEVICE(S): 3D MAPPING (CARTO 3 SYSTEM, BIOSENSE WEBSTER),STEERABLE DECAPOLAR CATHETER (DECANAV, BIOSENSE WEBSTER),MULTIELECTRODE MAPPING CATHETER (LASSO OR PENTARAY CATHETER, BIOSENSE WEBSTER) AND LASSO OR PENTARAY CATHETERS. -1 DEATH SECONDARY TO ACUTE MYOCARDIAL INFARCTION. THIS WILL NOT BE CAPTURED SINCE THIS HAPPENED MORE THAN 7 MONTHS AFTER CATHETER ABLATION. THIS WILL NOT BE CONSIDERED AS RELATED TO THE PROCEDURE. -THE PERICARDIAL EFFUSION APPEARED RELATIVELY DELAYED, MAKING IT DIFFICULT TO DETERMINE THE EXACT STEP OF THE PROCEDURE DURING WHICH IT OCCURRED. THIS WILL NOT BE CAPTURED SINCE THIS CANNOT BE DETERMINED WHETHER IT IS PROCEDURAL RELATED AS TO WHERE IT OCCURRED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_SMART TOUCH UNIDIRECTIONAL: QTY (B)(4). PATIENT HAD CARDIAC TAMPONADE IN THE NON/MINIMIZED FLUOROSCOPY GROUP. NO INTERVENTION MENTIONED. QTY (B)(4). PATIENTS HAD STROKE IN THE TRADITIONAL APPROACH GROUP (1 WAS A CEREBRAL HEMORRHAGE THAT OCCURRED 1 YEAR AFTER CATHETER ABLATION, OTHER WAS A CEREBRAL INFARCTION THAT OCCURRED ON THE 18TH DAY AFTER THE PROCEDURE. NO INTERVENTION MENTIONED. QTY (B)(4). PATIENTS HAD SICK SINUS SYNDROME IN THE NON/MINIMIZED FLUOROSCOPY GROUP. NO INTERVENTION MENTIONED. QTY (B)(4). PATIENTS HAD SICK SINUS SYNDROME IN THE TRADITIONAL APPROACH GROUP. NO INTERVENTION MENTIONED. QTY (B)(4). PATIENT HAD ESOPHAGEAL ULCER IN THE NON/MINIMIZED FLUOROSCOPY GROUP. NO INTERVENTION MENTIONED. QTY (B)(4). PATIENT HAD SYNCOPE WHICH INVOLVED HOSPITALIZATION IN THE TRADITIONAL APPROACH GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823365 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening 3D MAPPING (CARTO 3 SYSTEM)| LASSO OR PENTARAY CATHETERS| MULTIELECTRODE MAPPING CATHETER| STEERABLE DECAPOLAR CATHETER