BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12014662 · Received June 17, 2021

    Report

    Report Number
    2029046-2021-00945
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION AND MAGNETIC EVALUATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT REDDISH MATERIAL AND A HOLE IN THE PEBAX WERE OBSERVED ON THE SMART TOUCH UNIDIRECTIONAL CATHETER. MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THE EVALUATION DETERMINED THAT THE CAUSE OF PEBAX DAMAGE FAILURE CANNOT BE ESTABLISHED. THE EVENT DESCRIBED MAGNETIC DISTORTION WAS UNABLE TO DUPLICATE DURING THE PRODUCT INVESTIGATION. HOWEVER, THE BLOOD FOUND INSIDE THE PEBAX AREA MAY CONTRIBUTED TO THE UNABLE TO MAP REPORTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30471946M] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE CARTO 3 SYSTEM MANUAL: THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. REGARDING THE ADDITIONAL FINDING OBSERVED, THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING INFORMATION: 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. 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 · 1

    A PATIENT UNDERWENT AN ABLATION ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL¿ SMART TOUCH¿ SF BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTERS PRODUCT ANALYSIS LAB IDENTIFIED REDDISH MATERIAL AND A HOLE IN THE PEBAX. DURING THE PROCEDURE, A ERROR 401 WAS DISPLAYED ON THE CARTO SYSTEM. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO ADVERSE EVENT OR PATIENT CONSEQUENCES REPORTED ON THE PATIENT. THE ERROR 401 (MAPPING ERROR) IS NOT MDR-REPORTABLE. THE HOLE IN THE PEBAX IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914012 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LYB BIOSENSE WEBSTER INC 30471946M

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTO 3 SYSTEM