BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 23392915 · Received October 27, 2025

    Report

    Report Number
    2029046-2025-03576
    Event Type
    Death
    Date Received
    October 27, 2025
    Report Date
    October 27, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 DATABASE RELATED RESEARCH ACTIVITY (DRRA). THIS DRRA POTENTIAL COMPLAINT FORM - MEDTECH EPIDEMIOLOGY - BWI - THERMOCOOL SMARTTOUCH SF CATHETER RECEIVED IDENTIFIED THE FOLLOWING EVENTS PER TABLE 8: HEART BLOCK X2 PULMONARY EDEMA X2 CARDIAC TAMPONADE/ PERFORATION X3 1=15 DAYS AFTER THE INDEX PROCEDURE. DEATH X1 AT 88 DAYS POST PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THE EVENTS AND CORRESPONDING REPORTS HAVE BEEN SORTED IN THE FOLLOWING WAY. 1 REPORT TO CAPTURE: HEART BLOCK X2 PULMONARY EDEMA X2 CARDIAC TAMPONADE/ PERFORATION X2. 1 REPORT TO CAPTURE: CARDIAC TAMPONADE/ PERFORATION AT 15 DAYS AFTER THE INDEX PROCEDURE. 1 REPORT TO CAPTURE: THE DEATH AT 88 DAYS POST PROCEDURE. THIS REPORT IS FOR THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352607 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death