BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23613160 · Received November 20, 2025

    Report

    Report Number
    2029046-2025-03876
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009804
    PMA / PMN Number
    P030031/S078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH SF APPROVED UNDER P030031/S078. THE DEVICE EVALUATION DETAILS. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 23-OCT-2025. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND MAGNETIC SENSOR FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO ISSUES OR ERRORS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE MAGNETIC ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE CARTO® 3 SYSTEM INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: ENSURE THAT CATHETER VISUALIZATION INITIALIZATION HAS FINISHED. ENSURE THAT THE ELECTRODES SELECTED FOR MAPPING ARE OUT OF SHEATH. ENSURE THAT CONDITIONS FOR CATHETER VISUALIZATION ARE FULFILLED AND THE SELECTED MAPPING CATHETER IS VISUALIZED. DISCONNECT AND RECONNECT THE CATHETER AND ENSURE PROPER CONNECTION. REPLACE THE CATHETER OR THE CABLE; WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT; TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE, OR MAY DAMAGE THE CONTACT FORCE SENSOR. AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, THE ICON WAS WAGGLING ON THE CARTO SYSTEM SCREEN. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 29-OCT-2025, OBSERVED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE SURFACE OF THE PEBAX ON 29-OCT-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414631 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31606459L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_CARTO 3.