BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 20161235 · Received September 6, 2024

    Report

    Report Number
    2029046-2024-02990
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 12, 2024
    Report Date
    October 17, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 25-SEP-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 AV (ATRIOVENTRICULAR) NODE ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND WHEN THE CATHETER WAS BEING FLUSHED, NO FLUID WAS COMING OUT OF THE TIP OF THE CATHETER. LATER IN THE CASE, BEFORE WANTING TO PUT THE CATHETER BACK IN THE PATIENT, A FLUSH WAS ATTEMPTED BUT FAILED. IT WAS NOTICED THAT A CLOT HAD FORMED ON THE CATHETER TIP. ONCE THE CLOT WAS NOTED, THE CATHETER WAS NO LONGER USED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION, TEMPERATURE, IMPEDANCE, AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED, AND NO ISSUES WERE OBSERVED. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS FLUSHING CORRECTLY. NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31263118L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE THROMBUS/ CLOT AND IRRIGATION 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 INSTRUCTION FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: TO PREVENT THROMBOEMBOLISM, INTRAVENOUS HEPARIN (TARGET ACT OF > 350 S) SHOULD BE ADMINISTERED PRIOR TO OR IMMEDIATELY FOLLOWING TRANSSEPTAL PUNCTURE DURING AF ABLATION PROCEDURES; PURGE THE CATHETER AND THE IRRIGATION TUBING WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION OF THE CATHETER INTO THE PATIENT; ALWAYS MAINTAIN A CONSTANT HEPARINIZED NORMAL SALINE INFUSION TO PREVENT COAGULATION WITHIN THE LUMEN OF THE CATHETER. DO NOT USE THE CATHETER WITHOUT IRRIGATION FLOW; MAKE SURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO REINSERTION AS PART OF JOHNSON & JOHNSON MEDTECH¿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 AN AV (ATRIOVENTRICULAR) NODE ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND WHEN THE CATHETER WAS BEING FLUSHED, NO FLUID WAS COMING OUT OF THE TIP OF THE CATHETER. LATER IN THE CASE, BEFORE WANTING TO PUT THE CATHETER BACK IN THE PATIENT, A FLUSH WAS ATTEMPTED BUT FAILED. IT WAS NOTICED THAT A CLOT HAD FORMED ON THE CATHETER TIP. ONCE THE CLOT WAS NOTED, THE CATHETER WAS NO LONGER USED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236711 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31342124L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN GENERATOR.