BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 20904507 · Received December 11, 2024

    Report

    Report Number
    2029046-2024-03964
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 23, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009804
    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 31-DEC-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND FLUID (SALINE SOLUTION) ESCAPED FROM AN UNINTENDED LOCATION OF THE CATHETER (HANDLE, LUER HUB OR SHAFT), AND LEAKAGE CURRENT WAS DETECTED ON PATIENT INTERFACE UNIT (PIU) RL INPUT. THE MEDICAL TEAM CONFIRMED THAT THEY LOST SIGNAL ACROSS ALL ECG (ELECTROCARDIOGRAM) CHANNELS, BOTH BS (BODY SURFACE) AND IC (INTRACARDIAC). WHEN THE SIGNAL INTERFERENCE OCCURRED, THE AFFECTED CATHETER WAS INSIDE OF THE PATIENT'S BODY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, ELECTRICAL, AND IRRIGATION TESTS OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO SIGNAL LOSS OR ELECTRICAL ISSUES WERE OBSERVED. ALSO, THE DEVICE WAS CONNECTED FOR IRRIGATION TO CHECK ANY FLUID LEAKAGE: NO IRRIGATION/LEAKAGE ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31424984L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ELECTRICAL, CURRENT LEAKAGE AND DEVICE FLUID LEAKAGE ISSUES REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT MAY HAVE AFFECTED ITS PERFORMANCE. REGARDING CURRENT LEAKAGE, THE CARTO® 3 SYSTEM INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: DISCONNECT ALL CATHETER CABLES FROM THE PIU (PATIENT INTERFACE UNIT). IF THE ERROR PERSISTS AFTER DISCONNECTING ALL CATHETER CABLES FROM THE PIU, TURN OFF THE PIU POWER SUPPLY AND CONTACT BIOSENSE WEBSTER SERVICE AND SUPPORT DEPARTMENT TO REPORT A PIU ISSUE. IF THE ERROR MESSAGE DISAPPEARS AFTER DISCONNECTING ALL CATHETER CABLES, RECONNECT THE CATHETER CABLES, ONE BY ONE, UNTIL THE CATHETER OR CABLE CAUSING THE ERROR IS IDENTIFIED. REPLACE THE FAULTY CATHETER AND/OR CABLE. REGARDING THE FLUID LEAKAGE, THE DEVICE IFU STATES: "BEFORE USE, VERIFY THAT THE IRRIGATION PORTS ARE PATENT BY INFUSING HEPARINIZED NORMAL SALINE THROUGH THE CATHETER AND THE IRRIGATION TUBING." AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT COMPLAINT WILL BE ADDRESSED THROUGH THE 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® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND FLUID (SALINE SOLUTION) ESCAPED FROM AN UNINTENDED LOCATION OF THE CATHETER (HANDLE, LUER HUB OR SHAFT), AND LEAKAGE CURRENT WAS DETECTED ON PATIENT INTERFACE UNIT (PIU) RL INPUT. THE MEDICAL TEAM CONFIRMED THAT THEY LOST SIGNAL ACROSS ALL ECG (ELECTROCARDIOGRAM) CHANNELS, BOTH BS (BODY SURFACE) AND IC (INTRACARDIAC). WHEN THE SIGNAL INTERFERENCE OCCURRED, THE AFFECTED CATHETER WAS INSIDE OF THE PATIENT'S BODY. 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
    1732429 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31424984L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO® AND RECORDING SYSTEM.