BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8972892 · Received September 6, 2019

    Report

    Report Number
    2029046-2019-03611
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    July 18, 2019
    Report Date
    July 22, 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB HAS IDENTIFIED DAMAGED AND LIFTED RINGS. THE CUSTOMER INITIALLY REPORTED THAT DURING THE AF PROCEDURE, ERROR CODE '106' WAS DISPLAYED. THE SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED ISSUE OF ERROR 106 IS NOT MDR REPORTABLE SINCE THE WARNING FUNCTIONED AS INTENDED. ON (B)(6)2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND ¿RING #2 DENTED ON DISTAL END. THE POLYURETHANE (PU) PEELING AWAY FROM PROXIMAL END OF RING # 3. OPPOSITE OF RING # 3 THE PROXIMAL END IS DAMAGED AND LIFTED SLIGHTLY.¿ THESE FINDINGS WERE REVIEWED AND DETERMINED TO BE MDR REPORTABLE FOR THE LIFTED RINGS. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS INSPECTED AND RINGS # 2 AND 3 WERE FOUND DENTED. RING # 3 IS LIFTED WITH NO POLYURETHANE (PU) ON THE BORDER. THE 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. THE ROOT CAUSE OF THE ELECTRODE DAMAGE 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. ADDITIONALLY, THE CUSTOMER PROVIDED PHOTOS WITH EVIDENCE OF CODE ERROR 106 WAS OBSERVED ON THE CARTO 3 SCREEN AND IT IS RELATED TO FORCE SENSOR ISSUE. CUSTOMER COMPLAINT WAS CONFIRMED WITH PICTURES PROVIDED. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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 30174466M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB HAS IDENTIFIED DAMAGED AND LIFTED RINGS. THE CUSTOMER INITIALLY REPORTED THAT DURING THE AF PROCEDURE, ERROR CODE '106' WAS DISPLAYED. THE SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED ISSUE OF ERROR 106 IS NOT MDR REPORTABLE SINCE THE WARNING FUNCTIONED AS INTENDED. ON 8/15/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND ¿RING #2 DENTED ON DISTAL END. THE POLYURETHANE (PU) PEELING AWAY FROM PROXIMAL END OF RING # 3. OPPOSITE OF RING # 3 THE PROXIMAL END IS DAMAGED AND LIFTED SLIGHTLY.¿ THESE FINDINGS WERE REVIEWED AND DETERMINED TO BE MDR REPORTABLE FOR THE LIFTED RINGS. THIS EVENT WAS ORIGINALLY CONSIDERED NONREPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH VISUAL ANALYSIS ON 8/15/2019 AND HAS REASSESSED THIS COMPLAINT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766233 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC. 30174466M

    Patients

    Seq Age Sex Outcome Treatment
    1