BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8459635 · Received March 28, 2019

    Report

    Report Number
    2029046-2019-02879
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    January 25, 2019
    Report Date
    January 27, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY- IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ERROR CODE WAS 106 DISPLAYED, MAGNETIC SENSOR ERROR. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS VISUALLY INSPECTED, AND REDDISH MATERIAL WAS FOUND INSIDE THE PEBAX ALSO THE PEBAX WAS FOUND DAMAGE WITH TWO HOLES. THEN, MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER FAILED, ERROR 106 WAS OBSERVED. A FAILURE ANALYSIS WAS PERFORMED, AND THE CATHETER WAS DISSECTED ON THE TIP AREA, LOSS OF ELECTRICAL CONTINUITY AT THE SENSOR WAS FOUND, IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. IMPROVEMENTS HAVE BEEN IMPLEMENTED TO REDUCE MAGNETIC AND FORCE SENSOR INTERNAL ISSUES. THIS ISSUE IS HIGHLY DETECTABLE BY THE PHYSICIAN. 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 SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER'S REFERENCE #(B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30107724M NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND THAT THE CLEAR PEBAX SLEEVE HAS TWO DAMAGED AREAS. INITIALLY, IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN ERROR CODE WAS 106 DISPLAYED, MAGNETIC SENSOR ERROR. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE ERROR CODE 106 WHICH DISPLAYED WAS ASSESSED AS NOT REPORTABLE AS THE WARNING FUNCTIONED AS INTENDED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON MARCH 2, 2019, THAT THE CLEAR PEBAX SLEEVE HAS TWO DAMAGED AREAS. THE FIRST ONE WAS APPROXIMATELY 5.1 MM AND THE SECOND ONE WAS 5.2 MM FROM THE PROXIMAL END OF THE TIP DOME. DEFLECTED POSITION CLOSE-UP OF THE DAMAGED AREA AT 5.2 MM FROM THE PROXIMAL END OF THE TIP DOME HAS A HOLE. THE EVENT WAS ORIGINALLY CONSIDERED NOT REPORTABLE. HOWEVER, BIOSENSE WEBSTER BECAME AWARE OF THE DAMAGE TO THE CLEAR PEBAX SLEEVE ON MARCH 2, 2019 AND HAVE ASSESSED THIS ISSUE AS REPORTABLE. THE AWARENESS DATE IS MARCH 2, 2019 FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254095 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30107724M

    Patients

    Seq Age Sex Outcome Treatment
    1