BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 22668059 · Received July 30, 2025

    Report

    Report Number
    2029046-2025-02484
    Event Type
    Injury
    Date Received
    July 30, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    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. THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA), "INDICATION EXTENSION FOR MEDICAL DEVICES USING RWE FROM NESTCC NETWORK COLLABORATORS: SAFETY AND EFFECTIVENESS OF CARDIAC ABLATION OF ISCHEMIC VENTRICULAR TACHYCARDIA USING THE THERMOCOOL STSF CATHETER CLINICAL STUDY REPORT AMENDMENT: UPDATED ANALYSES". 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 DATABASE RELATED RESEARCH ACTIVITY (DRRA), "INDICATION EXTENSION FOR MEDICAL DEVICES USING RWE FROM NESTCC NETWORK COLLABORATORS: SAFETY AND EFFECTIVENESS OF CARDIAC ABLATION OF ISCHEMIC VENTRICULAR TACHYCARDIA USING THE THERMOCOOL STSF CATHETER CLINICAL STUDY REPORT AMENDMENT: UPDATED ANALYSES". ADVERSE EVENTS REPORTED FOR THERMOCOOL SMARTTOUCH® CATHETER: QTY 3: PERICARDIAL EFFUSION WITH HEMODYNAMIC COMPROMISE WITHIN 7 DAYS OF THE INDEX ABLATION PROCEDURE (CARDIAC TAMPONADE)(RECOGNIZED PROCEDURAL COMPLICATION) QTY 2: VASCULAR INJURY WITHIN 7 DAYS OF THE PROCEDURE (VASCULAR INJURY)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549872 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening UNK_SMART TOUCH UNIDIRECTIONAL SF