BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 22785932 · Received August 12, 2025

    Report

    Report Number
    2029046-2025-02659
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009514
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    ON 19-AUG-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. ON 1-SEP-2025, THE PHOTO ANALYSIS WAS COMPLETED. ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT BEFORE THE OPERATION, THE STERILIZATION PACKAGE WAS BROKEN (AS THE PHOTO SHOWS) AFTER THE CARTON WAS JUST OPENED. A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, A HOLE WAS OBSERVED ON THE PACKAGE OF THE POUCH OF THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31634137M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. ---- FURTHERMORE, PER INTERNAL REVIEW ON 11-SEP-2025, IT WAS DISCOVERED THAT AN H11 STATEMENT WAS MISTAKENLY OMITTED FROM THE PREVIOUS INITIAL REPORT. THE INFORMATION IS AS FOLLOWS: 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¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4),

    Additional Manufacturer Narrative · 0

    ON 16-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM FOUND THAT THE CATHETER'S STERILIZATION PACKAGE WAS ALREADY BROKEN AFTER THE CARTON WAS JUST OPENED. THIS DEVICE WAS NOT USED ON THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE EVALUATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, A HOLE WAS OBSERVED ON THE PACKAGE OF THE POUCH OF THE DEVICE. FURTHERMORE, THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH FOR EVALUATION. JOHNSON & JOHNSON MEDTECH THEN CONDUCTED VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED A HOLE IN THE POUCH; UPON CLOSER INSPECTION, IT WAS FOUND THAT THE DEVICE WAS NOT THE CAUSE OF THE DAMAGE. BASED ON THE MANUFACTURING INVESTIGATION, IT WAS DETERMINED THAT THE PERFORATED BAG FOUND WAS NOT RELATED TO MANUFACTURING. SINCE THE DEVICES IN THE BATCH WERE MANUFACTURED IN ACCORDANCE WITH PROCEDURES AND DULY COMPLIED WITH THE PROCEDURE INSPECTION, QUALITY INSPECTORS MUST CONDUCT A 200% INSPECTION OF THE PACKAGED DEVICES. THE QUALITY CONTROL INSPECTOR MUST VISUALLY VERIFY THAT THE PACKAGING IS FREE OF DAMAGE OR CONTAMINATION IN THE BAG, AND THAT THE SAMPLE INSPECTION HAS BEEN COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31634137M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE HOLE IN POUCH ISSUE COULD NOT BE DETERMINED. THE CATHETER INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT USE IF THE PACKAGE IS OPENED OR DAMAGED. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH JOHNSON & JOHNSON MEDTECH QUALITY SYSTEM 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¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM FOUND THAT THE CATHETER'S STERILIZATION PACKAGE WAS ALREADY BROKEN AFTER THE CARTON WAS JUST OPENED. THIS DEVICE WAS NOT USED ON 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
    2419288 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31634137M 10846835009514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown