BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24650618 · Received March 20, 2026

    Report

    Report Number
    2029046-2026-00933
    Event Type
    Injury
    Date Received
    March 20, 2026
    Report Date
    March 20, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    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 AND THE FOLLOWING CITATION WAS REVIEWED: YIN J, LI H, DU Z, LIANG J, LI T. HIGH-POWER SHORT-DURATION ABLATION OF THE SUPERIOR VENA CAVA: SAFETY AND EFFICACY USING THE RIGHT SUPERIOR PULMONARY VEIN ROOF AS A LANDMARK. BMC CARDIOVASC DISORD. 2025 DEC 30;25(1):904. DOI: 10.1186/S12872-025-05361-9. PMID: 41469946; PMCID: PMC12754943. D4. CATALOG: UNK_SMART TOUCH BIDIRECTIONAL. 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. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. NO: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: YIN J, LI H, DU Z, LIANG J, LI T. HIGH-POWER SHORT-DURATION ABLATION OF THE SUPERIOR VENA CAVA: SAFETY AND EFFICACY USING THE RIGHT SUPERIOR PULMONARY VEIN ROOF AS A LANDMARK. BMC CARDIOVASC DISORD. 2025 DEC 30;25(1):904. DOI: 10.1186/S12872-025-05361-9. PMID: 41469946; PMCID: PMC12754943. BACKGROUND AND PURPOSE: BACKGROUND: THE SUPERIOR VENA CAVA (SVC) IS A COMMON NON-PULMONARY VEIN TRIGGER SITE IN ATRIAL FIBRILLATION (AF), AND ITS ABLATION IMPROVES TREATMENT SUCCESS RATES. HOWEVER, CONVENTIONAL SVC ABLATION CARRIES RISKS OF SINOATRIAL NODE INJURY (SNI) AND PHRENIC NERVE INJURY (PNI) DUE TO ITS ANATOMICAL PROXIMITY TO THE SINOATRIAL NODE. THIS STUDY EVALUATED THE SAFETY AND EFFICACY OF HIGH-POWER SHORT-DURATION (HPSD) ABLATION OF THE SVC USING THE RIGHT SUPERIOR PULMONARY VEIN ROOF (RSPV ROOF) AS AN ANATOMICAL LANDMARK TO MINIMIZE COMPLICATIONS. METHODS: THIS RETROSPECTIVE STUDY ANALYZED 110 PATIENTS WITH PAROXYSMAL AF WHO UNDERWENT CIRCUMFERENTIAL PULMONARY VEIN ISOLATION (CPVI) COMBINED WITH SVC ISOLATION (SVCI). THE RSPV ROOF AND SVC JUNCTION WERE USED AS ANATOMICAL LANDMARKS. HPSD ABLATION (50 W/7 S) WAS PERFORMED WITHOUT PHRENIC NERVE(PN)MAPPING. THE ELECTRICAL SINOATRIAL NODE (ESAN) WAS DEFINED AS THE HIGHEST POINT OF THE EARLIEST ACTIVATION SITE DURING SINUS RHYTHM MAPPING.PATIENTS WERE DIVIDED INTO AN ESAN-MAPPED GROUP (N = 50) AND A NON-ESAN-MAPPED GROUP (N = 60). SAFETY AND EFFICACY OUTCOMES WERE COMPARED BETWEEN GROUPS. CONCLUSION: USING THE RSPV ROOF AND SVC JUNCTION AS ANATOMICAL LANDMARKS FOR SVC ISOLATION MAY OFFER A SAFE AND EFFECTIVE APPROACH. ADDITIONALLY, HPSD ABLATION (50 W/7 S) OF THE SVC WAS ACHIEVED WITHOUT THE USE OF ROUTINE PN MAPPING IN THIS COHORT, RESULTING IN SUCCESSFUL ISOLATION AND A LOW INCIDENCE OF TRANSIENT PNI. THIS SUGGESTS IT MAY REPRESENT A POTENTIAL ALTERNATIVE STRATEGY; HOWEVER, THE OCCURRENCE OF PNI UNDERSCORES THAT TECHNIQUES SUCH AS PN MAPPING REMAIN CRUCIAL FOR RISK MITIGATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: STSF CATHETER (SMART TOUCH SURROUND FLOW®; BIOSENSE WEBSTER). OTHER BWI DEVICE(S): CARTO 3 MAPPING SYSTEM, PENTARAY MAPPING CATHETER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICE(S): (N=12): 12 (10.9%) CASES OF PERICARDIAL EFFUSION POSTOPERATIVELY. ALL DOCUMENTED PERICARDIAL EFFUSIONS WERE MINOR (2¿4 MM IN DEPTH), LOCALIZED, AND ASYMPTOMATIC; NONE RESULTED IN HEMODYNAMIC COMPROMISE OR REQUIRED PERICARDIOCENTESIS. (N=2): 2 (1.8%) PATIENTS IN BOTH THE ESAN MAPPING AND NON-MAPPING GROUPS DEVELOPED PNI, BOTH OF WHICH OCCURRED DURING CIRCUMFERENTIAL SVC ABLATION, WITH COMPLETE RECOVERY OBSERVED WITHIN 1¿2 MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714766 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other CARTO 3 MAPPING SYSTEM.| PENTARAY MAPPING CATHETER.