BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24916402 · Received April 17, 2026

    Report

    Report Number
    2029046-2026-01265
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 17, 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

    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 CATHETER APPROVED UNDER P030031/S078. ON 24-MAR-2026, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION YELLOWISH MATERIAL ( PRESUMABLY BIOLOGICAL MATERIAL) AND A HOLE IN THE SURFACE OF THE PEBAX. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND NO 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 NUMBER 31722955L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE FORCE SENSOR ERROR 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: 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. A SIGNIFICANT CHANGE IN THE BASELINE READING AFTER CLEANING MIGHT INDICATE A DAMAGED CONTACT FORCE SENSOR. 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. REGARDING THE FORCE SENSOR ERROR REPORTED BY THE CUSTOMER, THE CARTO® 3 SYSTEM INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED 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 AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, AN ERROR106 ALERT CODE OCCURRED AFTER THE CATHETER WAS PLUGGED INTO THE CARTO AND BEFORE FIRST ABLATION AS TIP THREADED THROUGH DISTAL END OF SHEATH (DISTAL EXIT). THE FORCE VALUE COULD NOT BE ZEROED. THIS CATHETER WAS NOT USED INSIDE OF THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976065 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31722955L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown