BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24385716 · Received February 19, 2026

    Report

    Report Number
    2029046-2026-00559
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 18, 2026
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND MAGNETIC FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED FOREIGN REDDISH MATERIAL, PRESUMABLY BLOOD INSIDE THE PEBAX. THEN, THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO ERRORS WERE OBSERVED. THE MAGNETIC FEATURE WAS EVALUATED AND DISPLAYED PROPERLY. NO ISSUES WERE OBSERVED. FURTHER EXAMINATION UNDER MICROSCOPIC IMAGING REVEALED A HOLE IN THE PEBAX, AND THE REDDISH MATERIAL INSIDE IT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE SENSOR 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 CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. THE CATHETER INSTRUCTION FOR USE (IFU) RECOMMENDS: 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 AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND DURING THE OPERATION, THE MAGNETIC SENSOR ISSUE/ERROR WAS DISPLAYED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND MAGNETIC FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED FOREIGN REDDISH MATERIAL, PRESUMABLY BLOOD INSIDE THE PEBAX. A HOLE IN THE PEBAX WAS FOUND AS WELL. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449805 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31673430L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown