BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 23070529 · Received September 17, 2025

    Report

    Report Number
    2029046-2025-03187
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    January 1, 2021
    Report Date
    September 17, 2025
    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

    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: DONG S, CUI L, LI J, HAN Y, CHU Y. EFFECT AND PROGNOSIS OF SUPERIOR VENA CAVA ISOLATION IN CATHETER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. HENAN MEDICAL RESEARCH SEPT. 2021,VOL. 30,NO. 27. DOI: 10. 3969 /J. ISSN. 1004 - 437X. 2021. 27. 003. 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: DONG S, CUI L, LI J, HAN Y, CHU Y. EFFECT AND PROGNOSIS OF SUPERIOR VENA CAVA ISOLATION IN CATHETER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. HENAN MEDICAL RESEARCH SEPT. 2021,VOL. 30,NO. 27. DOI: 10. 3969 /J. ISSN. 1004 - 437X. 2021. 27. 003. BACKGROUND: IN RECENT YEARS, CATHETER ABLATION HAS BEEN GREATLY DEVELOPED AND IS THE MAINSTREAM METHOD FOR THE TREATMENT OF ATRIAL FIBRILLATION (AF). SINCE MOST ATRIAL FIBRILLATION ORIGINATES FROM THE PULMONARY VEINS, CIRCUMFERENTIAL PULMONARY VEIN ISOLATION (CPVI) HAS BECOME THE CORNERSTONE OF CATHETER ABLATION FOR ATRIAL FIBRILLATION. HOWEVER, IN SOME PATIENTS, ATRIAL FIBRILLATION DOES NOT ORIGINATE FROM THE PULMONARY VEINS, AND CPVI ALONE CANNOT ACHIEVE THE PURPOSE OF TREATMENT. OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF SUPERIOR VENA CAVA ISOLATION ( SVCI) IN CATHETER ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION. METHODS: A TOTAL OF 112 PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION WHO RECEIVED CATHETER ABLATION WERE ENROLLED IN THIS STUDY. ALL PATIENTS UNDERWENT CIRCUMFERENTIAL PULMONARY VEIN ISOLATION ( CPVI). SVCI WERE UNDERWENT ONLY IF SVC - ORIGINATED ATRIAL FIBRILLATION IN PVI GROUP ( 59 CASES),WHILE EMPIRICAL SVCI WERE UNDERWENT IN PVI + SVCI GROUP ( 53 CASES) . THE OPERATION TIME, X - RAY EXPOSURE, COMPLICATIONS AND RECURRENCE OF AF WERE COMPARED BETWEEN THE TWO GROUPS, AND THE PREDICTIVE FACTORS OF ATRIAL FIBRILLATION RECURRENCE WERE ANALYZED. CONCLUSIONS: SVCI IS TECHNICALLY SAFE AND FEASIBLE. AN EMPIRIC SVCI IN ADDITION TO THE CPVI DOES NOT IMPROVE THE SUCCESS RATE OF THE FIRST CATHETER ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION. LEFT ATRIAL DIAMETER AND EARLY RECURRENCE WERE INDEPENDENT RISK FACTORS FOR THE RECURRENCE OF ATRIAL FIBRILLATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOLSMARTTOUCH SF ABLATION CATHETER (BIOSENSE WEBSTER). OTHER BWI PRODUCTS: PENTARAY MAPPING CATHETER (BIOSENSE WEBSTER), TEN-LEVEL MAPPING ELECTRODE CATHETER (BIOSENSE WEBSTER) AND CARTO-3 THREE-DIMENSIONAL ELECTRICAL MAPPING SYSTEM (BIOSENSE WEBSTER). NON-BWI DEVICES: UNKNOWN MANUFACTURER 6F (1F = 0.33 MM) SHEATH AND 8.5 FR SWARTZ LONG SHEATH (ST. JUDE MEDICAL, SL1). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 CASE OF PERICARDIAL TAMPONADE. NO INTERVENTION MENTIONED. QTY 2: 2 CASES OF PERICARDIAL EFFUSION OCCURRED. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598111 UNK_SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening 8.5 FR SWARTZ LONG SHEATH (ST. JUDE MEDICAL, SL1).| THERMOCOOLSMARTTOUCH SF| UNKNOWN 6F SHEATH