BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16357946 · Received February 10, 2023

    Report

    Report Number
    2029046-2023-00264
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 13, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009194
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 21-FEB-2023. THE DEVICE EVALUATION WAS COMPLETED ON 01-MAR-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THERE WERE TEMPERATURE SPIKES AND NO ECG SIGNALS ON ALL CHANNELS WERE OBSERVED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, ELECTRICAL TEST, AND TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE NOR ANOMALIES ON THE DEVICE. AN ELECTRICAL TEST WAS PERFORMED, AND NO ELECTRICAL ISSUES WERE FOUND. THE TEMPERATURE AND IMPEDANCE TEST WERE PERFORMED AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30874596M] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ELECTRICAL AND TEMPERATURE ISSUES REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATION: IF THE RADIOFREQUENCY (RF) GENERATOR DOES NOT DISPLAY TEMPERATURE, VERIFY THAT THE APPROPRIATE CABLE IS PLUGGED INTO THE RF GENERATOR. AS PART OF BIOSENSE WEBSTER¿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 A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THERE WERE TEMPERATURE SPIKES AND NO ECG SIGNALS ON ALL CHANNELS WERE OBSERVED. BROKEN SENSOR WAS REPORTED. WHEN CONNECTED, ALL THE SIGNALS DISAPPEARED AND NOTHING WAS WORKING. TEMPERATURE SPIKES UP TO 65°C WAS RECORDED ON THE SMARTABLATE RF GEN. THERE WAS NO SURGICAL DELAY. USERS ATTEMPTED TO RESOLVE BY CHANGING CABLE AND THEN CHANGING CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED FROM THE EVENT. THERE WAS NO PATIENT CONSEQUENCE. THE SIGNAL LOSS WAS OBSERVED ON ALL CHANNELS AND LOST ON BOTH CARTO AND RECORDING SYSTEM. DURING THE SIGNAL LOSS, THE AFFECTED CATHETER WAS NOT INSIDE THE PATIENT¿S BODY. TEMPERATURE SPIKES OCCURRED AS SOON AS THE CATHETER WAS CONNECTED. BESIDES TEMPERATURE SENSOR, MAPPING CATHETER SENSOR ERROR HAPPENED AS SOON AS THE CATHETER WAS CONNECTED. THE HIGH TEMPERATURE ISSUE IS MDR REPORTABLE. THE ISSUE OF NO ECG SIGNALS ON ALL CHANNELS IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079985 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132704 30874596M 10846835009194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THMCL SMRTTCH,BI,NAV,TC,F-J,C3| UNK BRAND CABLE| UNK BRAND CABLE| UNK_CARTO 3| UNK_SMARTABLATE GENERATOR