BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17805394 · Received September 24, 2023

    Report

    Report Number
    2029046-2023-02155
    Event Type
    Malfunction
    Date Received
    September 24, 2023
    Date of Event
    July 11, 2023
    Report Date
    September 24, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND A HOLE WAS OBSERVED ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THE ROOT CAUSE OF THE DAMAGE ON PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. HOWEVER, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, BUT THIS CANNOT BE CONCLUSIVELY DETERMINED. THEN, THE CATHETER WAS CONNECTED TO CARTO 3, AND ERROR 105 WAS OBSERVED DUE TO AN OPEN CIRCUIT INSIDE THE TIP. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 31010124L, AND NO INTERNAL ACTIONS WERE IDENTIFIED. AS PART OF BIOSENSE WEBSTER'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 ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX. DURING THE PROCEDURE, WHEN RADIOFREQUENCY (RF) ENERGY WAS APPLIED TO THE SMARTTOUCH CATHETER THE MEDICAL TEAM LOST VISUALIZATION OF THE CATHETER AND THE FORCE READINGS WERE INACCURATE. CHANGING OUT THE CATHETER CABLE DID NOT RESOLVE THE ISSUE. THE CATHETER WAS CHANGED AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THE INACCURATE FORCE READING IS NOT MDR-REPORTABLE. LOST VISUALIZATION IS NOT MDR-REPORTABLE. HOLE IN THE PEBAX IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835136 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31010124L 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown