BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24570250 · Received March 11, 2026

    Report

    Report Number
    2029046-2026-00802
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    December 14, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009811
    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 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 THAT THE PEEK HOUSING WAS FOUND BROKEN LEAVING THE INTERNAL COMPONENTS EXPOSED. A FORCE TEST WAS PERFORMED AND THE DEVICE WAS RECOGNIZED AND VISUALIZED CORRECTLY; HOWEVER ERROR 106 DISPLAYED ON SCREEN. DUE TO THIS CONDITION, THE HANDLE OF THE DEVICE WAS DISSECTED, AND RESISTANCE OF THE SENSOR PADS ON THE PRINTED CIRCUIT BOARD (PCB) WAS MEASURED AND THE RESULTS WERE FOUND OUT OF SPECIFICATIONS. A DISSECTION WAS PERFORMED RIGHT AFTER AT THE TIP AREA AND AN OPEN CIRCUIT WAS IDENTIFIED. IN ADDITION, FURTHER INVESTIGATION OF THE PEEK HOUSING SECTION REVEALED THAT THERE WAS INSUFFICIENT ADHESIVE (POLYURETHANE - PU) ON THE WIRES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31620724L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE FORCE SENSOR ERROR REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE ADHESIVE CONDITION WAS TRACED TO THE MANUFACTURING PROCESS. THE PEEK HOUSING CONDITION WAS NOT RELATED TO THE REPORTED EVENT AND THE POTENTIAL CAUSE COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CAN NOT BE CONCLUSIVELY DETERMINED. 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. 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. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. 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 A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE PEEK HOUSING WAS FOUND BROKEN LEAVING THE INTERNAL COMPONENTS EXPOSED. DURING THE PROCEDURE, A 106 ALERT CODE OCCURRED AFTER CATHETER PLUGGED INTO CARTO AND BEFORE FIRST ABLATION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. CATHETER WAS NOT USED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629654 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31620724L 10846835009811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown