BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24734691 · Received March 30, 2026

    Report

    Report Number
    2029046-2026-01022
    Event Type
    Injury
    Date Received
    March 30, 2026
    Report Date
    March 30, 2026
    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

    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 ARTICLE HAS BEEN REVIEWED: LIN Y, LIN Q, ZHAO L, LIANG X, LIU F, ZHAO Q. AN INTEGRATED APPROACH TO RADIOFREQUENCY ABLATION OF PARA-HISIAN ACCESSORY PATHWAYS IN PAEDIATRIC PATIENTS. HEART RHYTHM. 2026 JAN 8:S1547-5271(26)00017-2. DOI: 10.1016/J.HRTHM.2026.01.002. EPUB AHEAD OF PRINT. PMID: 41519350. 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 ARTICLE HAS BEEN REVIEWED: LIN Y, LIN Q, ZHAO L, LIANG X, LIU F, ZHAO Q. AN INTEGRATED APPROACH TO RADIOFREQUENCY ABLATION OF PARA-HISIAN ACCESSORY PATHWAYS IN PAEDIATRIC PATIENTS. HEART RHYTHM. 2026 JAN 8:S1547-5271(26)00017-2. DOI: 10.1016/J.HRTHM.2026.01.002. EPUB AHEAD OF PRINT. PMID: 41519350. BACKGROUND: PAEDIATRIC PARA-HISIAN ACCESSORY PATHWAY (PHAP) ABLATION CARRIES GREATER CHALLENGES THAN IN ADULTS DUE TO SMALLER KOCH¿S TRIANGLES. OBJECTIVES: WE AIMED TO DEVELOP AN ABLATION STRATEGY TO ENHANCE BOTH EFFICACY AND SAFETY IN THIS POPULATION. METHODS: THIS SINGLE-CENTRE RETROSPECTIVE STUDY INCLUDED 41 PAEDIATRIC PATIENTS (MEDIAN AGE 10 YEARS) BETWEEN JANUARY 2023 AND SEPTEMBER 2025. THE STRATEGY COMPRISED: (1) PACE-MAPPING VALIDATION OF VENTRICULAR INSERTION SITES IN MANIFEST PATH WAYS, USING ADENOSINE-INDUCED MAXIMAL PRE-EXCITATION AS A TEMPLATE; AND (2) SUBVALVULAR RETROFLEXION FOR CATHETER STABILISATION IN PATIENTS =10 KG. ENERGY DELIVERY WAS TITRATED WITH GUIDANCE FROM PARA-HISIAN PACING TO DISTINGUISH NEAR-FIELD HIS SIGNALS, AND ATRIAL OVERDRIVE PACING WAS USED TO MONITOR AV CONDUCTION DURING ANY JUNCTIONAL ACCELERATION. CONCLUSIONS: OUR INTEGRATED ABLATION STRATEGY EFFECTIVELY ADDRESSES THE UNIQUE CHALLENGES OF PAEDIATRIC PHAP ABLATION, ACHIEVING DURABLE EFFICACY AND HIGH PROCEDURAL SAFETY. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SOFTER IRRIGATED CATHETER (THERMOCOOL¿, BIOSENSE WEBSTER), STIFFER CONTACT FORCE-SENSING CATHETER (SMARTTOUCH¿, BIOSENSE WEBSTER). OTHER BWI PRODUCTS: 3D ELECTROANATOMIC SYSTEM (CARTO, BIOSENSE WEBSTER). NON-BWI DEVICES: SR-0 LONG SHEATH (ABBOTT), AGILIS¿ STEERABLE SHEATH (ABBOTT), LABSYSTEM PRO MULTICHANNEL SYSTEM (BARD ELECTROPHYSIOLOGY). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: UNK_THERMOCOOL SF NON NAV QTY 1: (B)(4) CASE OF FIRST-DEGREE AV BLOCK TRANSIENT CONDUCTION DISTURBANCES. QTY 3: (B)(4) CASES OF MOBITZ I CONDUCTION DISTURBANCES. QTY 12: (B)(4) CASES OF JUNCTIONAL RHYTHM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: UNK_SMART TOUCH UNIDIRECTIONAL QTY 1: 1 PATIENT A 1 YEAR-OLD WAS FOUND TO HAVE A DEVELOPED A SUPERIOR MID-PARASEPTAL AP CASE, A PERSISTENT INCOMPLETE RIGHT BUNDLE BRANCH BLOCK DURING THE REVERSE-C MANOEUVRE, THIS DID NOT AFFECT COMPLETION OF THE PROCEDURE AND SHOWED NO PROGRESSION DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789029 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening