BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19452072 · Received June 3, 2024

    Report

    Report Number
    2029046-2024-01793
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    January 9, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION. A VISUAL INSPECTION AND SCREENING TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. THE EVALUATION HAS BEEN COMPLETED VISUAL ANALYSIS REVEALED A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION AND A FOREIGN MATERIAL INSIDE OF IT. A SCREENING TEST WAS PERFORMED, AND THE DEVICE WAS RECOGNIZED AND VISUALIZED CORRECTLY; HOWEVER NEGATIVE FORCE VECTOR APPEARED IN THE SYSTEM WITH HIGH FORCE READINGS DUE TO INSUFFICIENT ADHESIVE APPLICATION ON THE WIRES INSIDE THE TIP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) STATES: WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT; TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE OR MAY DAMAGE THE CONTACT FORCE SENSOR. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. IN ORDER TO ACHIEVE OPTIMAL FORCE READING ACCURACY AND STABILITY, ALLOW THE CATHETER TO WARM UP FOR 2 MINUTES AFTER CONNECTION TO THE CARTO¿ 3 SYSTEM, PRIOR TO USE OF THE FORCE FEEDBACK FEATURE. ZERO THE CONTACT FORCE READING WHEN MOVING THE CATHETER FROM ONE CHAMBER OF THE HEART TO ANOTHER OR UPON REINSERTION. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AN INTERNAL ACTION WAS CREATED FOR FURTHER INVESTIGATION OF THE FORCE SENSOR SLEEVE INSOLATION TO PREVENT FLUIDS TO GET INSIDE INTO THE DEVICE AND TO REDUCE FORCE VECTOR INVERTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A MATERIAL SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS A PROBLEM WITH CONTACT FORCE MEASUREMENT AND THE VECTOR FORCE DISAPPEARED AS SOON AS THE ABLATION SHOT WAS STARTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. THERE WAS NO INFORMATION PROVIDED ON HOW THEY RESOLVED THE ISSUE DURING THE PROCEDURE. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 8-MAY-2024 THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION AND A FOREIGN MATERIAL INSIDE IT. THESE FINDING WAS REVIEWED AND ASSESSED AS MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865070 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31066236LB 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown