BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8367531 · Received February 25, 2019

    Report

    Report Number
    2029046-2019-02729
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    July 1, 2018
    Report Date
    February 1, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS INSPECTED AND METAL WAS FOUND EXPOSED AT THE TIP. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS OBSERVED UNDER THE X RAY MACHINE AND THE T BAR WAS FOUND SLID DOWN CAUSING THE IMPROPER DEFLECTION CONDITION AND CAUSING THE T BAR EXPOSURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE T BAR SLIPPAGE CANNOT BE DETERMINED, HOWEVER, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE ISSUE OF THE T BAR SLIDING DOWN. MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND BIOSENSE WEBSTER INC. (BWI) HAS IDENTIFIED AN MDR REPORTABLE MALFUNCTION AS THE RETURNED CATHETER WAS FOUND TO HAVE FOUND ¿METAL EXPOSED ON THE TIP APPROXIMATELY 26 MM FROM THE DOME.¿ IT WAS REPORTED THAT DURING THE PROCEDURE THE STEERING MECHANISM OF THE CATHETER WAS DEFECTIVE AND THE PHYSICIAN WASN'T ABLE TO CONTROL THE CATHETER PROPERLY. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE OF INADEQUATE DEFLECTION STEERING MECHANISM IS NOT MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT IS REMOTE. ON 1/18/2019, THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND NO PHYSICAL DAMAGE. ON 2/1/2019, DURING A SECOND VISUAL ANALYSIS ¿METAL WAS FOUND EXPOSED ON THE TIP APPROXIMATELY 26 MM FROM THE DOME.¿ THIS FINDING HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH VISUAL ANALYSIS ON 02/01/2019 AND HAS REASSESSED THIS COMPLAINT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161602 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30046623M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1