BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21223838 · Received January 23, 2025

    Report

    Report Number
    2029046-2025-00250
    Event Type
    Injury
    Date Received
    January 23, 2025
    Report Date
    April 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL REPORT: REPORT SUBMISSION DUE DATE HAS BEEN UPDATED FROM 27-JAN-2025 TO 26-JAN-2025 AND G 3. DATE RECEIVED BY MANUFACTURER WAS UPDATED FROM 28-DEC-2024 TO 27-DEC-2024. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED PERFORMING A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31425163L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED A "CARDIAC INFARCTION" THAT REQUIRED MEDICAL INTERVENTION. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO DELIVER RADIOFREQUENCY WITH THE CATHETER BECAUSE ITS TEMPERATURE WAS RISING TOO HIGH (ABOVE 40 °C).THE GENERATOR¿S SAFETY FEATURE WAS STOPPING THE RADIOFREQUENCY DELIVERY 1 OR 2 SECONDS AFTER THE BEGINNING OF THE ABLATION. ALL THE ABLATION PARAMETERS WERE CHECKED, AND THE IRRIGATION RATE WAS CORRECT, EXCEPT DURING THE FIRST ATTEMPT, IT WAS SLIGHTLY LOWER THAN NEEDED DUE TO A PLASTIC TAP. THEY CHANGED THE CATHETER CABLE, BUT THIS DID NOT RESOLVE THE ISSUE. THE GENERATOR WAS AN OZYPKA GENERATOR, FROM THE STEREOTAXIS COMPANY. THEY ATTEMPTED TO DELIVER RADIOFREQUENCY ONLY THREE TIMES, AS 3-5 MINUTES AFTER THE FIRST ATTEMPT, THE PATIENT BEGAN TO EXPERIENCE A CARDIAC INFARCTION, AND SO THEY STOPPED THE PROCEDURE. THE CATHETER WAS CHECKED, IRRIGATION WAS NORMAL, AND THERE WAS NO CHAR. THE INFARCTION WAS TREATED WITH MEDICATION, AND THE PATIENT¿S ELECTROCARDIOGRAM (ECG) RETURNED TO NORMAL AFTER A FEW MINUTES. AFTERWARD, THE PATIENT UNDERWENT A CORONARY ANGIOGRAPHY, WHICH SHOWED NO ABNORMALITIES. THE HIGH TEMPERATURE ISSUE IS NOT MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723047 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31425163L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L STEREOTAXIS OZYPKA GENERATOR.| UNK CABLE.