BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4093615 · Received September 16, 2014

    Report

    Report Number
    2029046-2014-00301
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE CATHETER STOPPED DEFLECTING ON THE "J" CURVE. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND THE SHAFT WAS TWISTED WITH THE BRAID BROKEN AND BREAKING OUT OF THE HOLES AND INTERNAL PARTS EXPOSED ABOUT 9 CM FROM THE CLIENT TIP. THESE CONDITIONS WERE NOT ORIGINALLY REPORTED BY THE CUSTOMER. CLARIFICATION WAS REQUESTED TO THE BWI FIELD REPRESENTATIVE BUT NO RESPONSE WAS RECEIVED. ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. IT REMAINS UNKNOWN HOW THE SHAFT WAS DAMAGED. DUE TO THE EXPOSED BRAID, AN ELECTRICAL TEST WAS PERFORMED AND CATHETER PASSED. THEREFORE, WE CAN CONCLUDE ALL THE ELECTRICAL WIRES WERE INSULATED. PER THE COMPLAINT, THE CATHETER WAS TESTED FOR DEFLECTION AND THE CATHETER FAILED. AFTERWARDS, THE CATHETER WAS DISSECTED AND THE PULLER WIRE WAS FOUND DETACHED FROM T BAR, CAUSING THE DEFLECTION ISSUE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED AND AVOID TWISTING THE CATHETER TO PREVENT ANY DAMAGE. THE REPORTED CUSTOMER COMPLAINT HAS BEEN VERIFIED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE THERMOCOOL SMART TOUCH BROKEN SHAFT ISSUE.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND PER THE BWI FAILURE ANALYSIS FINDING, THE CATHETER WAS RETURNED WITH THE BRAID BROKEN AND EXPOSED. THE INTERNAL PARTS WERE ALSO EXPOSED. IT WAS REPORTED THAT THIS CATHETER STOPPED DEFLECTING ON THE "J" AFTER ABOUT 2 HOURS DURING THE PROCEDURE. THE CATHETER WAS EXCHANGED AND THE SECOND CATHETER STOPPED DEFLECTING ON THE "J" CURVE AFTER ABOUT 5 MINUTES. THE SECOND CATHETER WAS NOT EXCHANGED AND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. UPON VISUAL INSPECTION OF ONE OF THE RETURNED COMPLAINT CATHETERS ((B)(4)) ON (B)(4) 2014, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE SHAFT WAS TWISTED AND WRINKLED WITH THE BRAID BROKEN AND EXPOSED. THE INTERNAL PARTS WERE ALSO EXPOSED ABOUT 9 CM FROM THE CLIENT TIP. THE EVENT WAS ORIGINALLY CONSIDERED NOT REPORTABLE. HOWEVER, THE RETURNED CATHETER CONDITION NOTED ON (B)(4) 2014 HAS BEEN ASSESSED AS REPORTABLE. THE AWARENESS DATE WAS UPDATED FOR THIS RECORD FROM (B)(4) 2014 AS WHEN THE ISSUE WAS FOUND FROM THE BWI FAILURE ANALYSIS LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572884 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1327-04-S 16104774M

    Patients

    Seq Age Sex Outcome Treatment
    1