BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 23052760 · Received September 15, 2025

    Report

    Report Number
    2029046-2025-03153
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    May 23, 2025
    Report Date
    September 15, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010220
    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® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S078. THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION REVEALED AN ELECTRODE LIFTED AND A FOREIGN MATERIAL UNDER AN ELECTRODE ON THE TIP. PROPER MANUFACTURING EVIDENCE OF ASSEMBLY WAS NOTED ON THE LIFTED ELECTRODE. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND IT WAS RECOGNIZED CORRECTLY, HOWEVER, ERRORS 105 AND 106 DISPLAYED. FOR THIS REASON, AN ELECTRICAL TEST WAS PERFORMED AND NO ELECTRICAL ISSUES WERE OBSERVED. THE ERRORS OBSERVED ON SCREEN WERE DISPLAYED DUE TO AN OPEN CIRCUIT AT THE TIP AREA. ADDITIONALLY, THE DEVICE WAS DISSECTED AT THE PEEK HOUSING SECTION AND INSUFFICIENT ADHESIVE APPLICATION ON THE WIRES WAS OBSERVED. A FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FT-IR) ANALYSIS WAS REQUESTED TO IDENTIFY THE FOREIGN MATERIAL. OVERALL, THE FT-IR DATA REVEALS THAT FOREIGN PARTICLES EXHIBIT ABSORPTION BANDS CHARACTERISTIC OF POLYESTER MATERIAL, SPECIFICALLY POLYETHYLENE TEREPHTHALATE (PET). THE SOURCE OF ORIGIN CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31413203L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE LIFTED ELECTRODE CONDITION COULD BE RELATED TO THE CURRENT LEAKAGE REPORTED BY THE CUSTOMER. THE SENSOR ERRORS, AND FOREIGN MATERIAL ARE UNRELATED TO THE ISSUE REPORTED BY THE CUSTOMER. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT, ELECTRODE LIFTED AND FOREIGN MATERIAL COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE ADHESIVE CONDITION WAS TRACED TO THE MANUFACTURING PROCESS. THE 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 THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. INTERNAL ACTIONS ARE BEING PERFORMED TO ADDRESS PROCESS OPPORTUNITIES RELATED TO ADHESIVE ISSUES. 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 ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A LIFTED ELECTRODE AND A FOREIGN MATERIAL UNDERNEATH AN ELECTRODE ON THE TIP. DURING THE PROCEDURE, LEAKAGE CURRENT WAS DETECTED ON PATIENT INTERFACE UNIT RL INPUT. 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
    1722616 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31413203L 10846835010220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown