BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 25233051 · Received May 20, 2026

    Report

    Report Number
    2029046-2026-01624
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 20, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009507
    PMA / PMN Number
    P030031/S053
    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/S053. 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 TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED REDDISH BROWN MATERIAL INSIDE THE PEBAX AND A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. A TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. AN IRRIGATION TEST WAS PERFORMED AND NO IRRIGATION ISSUER WERE FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31785165M AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE HIGH TEMPERATURE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE PEBAX DAMAGE IS TRACED TO THE MANUFACTURING PROCESS. 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 TO 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 PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. AN INTERNAL ACTION WAS CREATED FOR FURTHER INVESTIGATION OF THE FORCE SENSOR SLEEVE INSOLATION TO PREVENT FLUIDS TO GET INSIDE INTO THE DEVICE. 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 CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. DURING THE PROCEDURE, THERE WAS A HIGH TEMPERATURE READING FROM THE CATHETER WHEN RADIOFREQUENCY (RF) WAS BEING DELIVERED. 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
    559984 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31785165M 10846835009507

    Patients

    Seq Age Sex Outcome Treatment
    1