BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22535499 · Received July 17, 2025

    Report

    Report Number
    2029046-2025-02374
    Event Type
    Death
    Date Received
    July 17, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 17, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31620964L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 17-JUL-2025, NOTED A CORRECTION TO THE 3500A INITIAL, UNDER THE D4. PRIMARY UDI NUMBER AS IT SHOULD HAVE BEEN PROCESSED AS (B)(4). THEREFORE, CORRECTED. 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 AT THE END OF A PERSISTENT ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE TREATED WITH A PERICARDIAL DRAINAGE. IN ADDITION, THE PATIENT HAD A CARDIAC ARREST AND SUBSEQUENTLY THE PATIENT EXPIRED. AT THE END OF THE PROCEDURE, TAMPONADE WAS DETECTED. THE PATIENT WAS NOT WAKING UP, WITH A DROP IN BLOOD PRESSURE. TRANSTHORACIC ECHOCARDIOGRAM TO CONFIRM TAMPONADE AND PERICARDIAL DRAINAGE. CARDIAC ARREST ON THE TABLE AND PATIENT DEATH REPORTED. POSSIBLE CAUSES WERE ABLATION IN THE CORONARY SINUS, LOSS OF TRANSSEPTAL ACCESS FOLLOWED BY MULTIPLE ATTEMPTS TO RE-ENTER THE LEFT ATRIUM. THE BIOSENSE EQUIPMENT WAS NOT IMPLICATED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664356 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31620964L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D CARTO 3 SYSTEM.| PENTARAY NAV ECO 7FR, F, 2-6-2.| SMARTABLATE GENERATOR KIT-WW.