BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24627746 · Received March 18, 2026

    Report

    Report Number
    2029046-2026-00904
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    January 23, 2026
    Report Date
    March 18, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, MAGNETIC AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO MAGNETIC ISSUES OR ERRORS WERE OBSERVED. THE FORCE FEATURE OF THE DEVICE WAS EVALUATED, AND THE FORCE VALUES AND THE VECTOR WERE OBSERVED WITHIN SPECIFICATIONS. NO FORCE ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE MAGNETIC AND FORCE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE PEBAX DAMAGE IS TRACED TO THE MANUFACTURING PROCESS. AN INTERNAL CORRECTIVE ACTION WAS CREATED FOR FURTHER INVESTIGATION OF THE FORCE SENSOR SLEEVE INSOLATION TO PREVENT FLUIDS FROM GETTING INSIDE INTO THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT SCRUB OR TWIST THE TIP ELECTRODE BECAUSE DAMAGE TO THE TIP ELECTRODE BOND MAY OCCUR AND LOOSEN THE TIP ELECTRODE, OR DAMAGE THE CONTACT FORCE SENSOR AND AFFECT MEASUREMENT ACCURACY. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, VERIFY COMPATIBILITY BETWEEN THE SHEATH AND CATHETER, ADVANCE THE CATHETER THROUGH THE SHEATH PRIOR TO INSERTION. ANY SHEATH < 8.5 F IS CONTRAINDICATED. 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 ATRIOVENTRICULAR (AV) NODE ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF, AND WHEN COMING ON ABLATION, THERE WERE HIGH FORCE READINGS, AND INTERMITTENT HIGH MAGNETIC FIELD ISSUES. THERE WERE NO ERRORS DISPLAYED. THE CATHETER AND CABLE WERE RESEATED WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CATHETER TIP WAS WIPED AND THERE WAS BLOOD INSIDE THE SENSOR COIL TUBING. THE REPORTER NOTED THAT IT WAS A BRAND-NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. 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, MAGNETIC AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691330 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31728717L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown