BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 4263121 · Received November 19, 2014

    Report

    Report Number
    9673241-2014-00501
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ON THE INITIAL VISUAL INSPECTION WHEN THE DEVICE WAS RETURNED, IT WAS DISCOVERED THAT THE CATHETER HAS A REDDISH COLORED LEAD WIRE THAT WAS EXPOSED. THIS FINDING WAS ORIGINALLY ASSESSED AS REPORTABLE BECAUSE AN EXPOSED WIRE HAS THE POTENTIAL TO CAUSE A SERIOUS INJURY TO THE PATIENT. AFTER COMPLETE ANALYSIS OF THE RETURNED PRODUCT, IT WAS DISCOVERED THAT THE LEAD WIRE IS NOT EXPOSED BUT JUST VISUALIZED. THIS WIRE IS ACTUALLY COVERED BY POLYURETHANE AND THE WIRE IS PART OF THE PRODUCT DESIGN. SINCE THE WIRE IS NOT ACTUALLY EXPOSED, THERE IS NO RISK TO THE PATIENT AND THIS FINDING HAS BEEN RE-ASSESSED AS NOT REPORTABLE AS THE WIRE IS NOT ACTUALLY EXPOSED BUT VISUALIZED AS PART OF THE CATHETER DESIGN. (B)(4) IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN EZ STEER THERMOCOOL NAVIGATIONAL 4MM CATHETER AND THE IMPEDANCE DISPLAYED AROUND 900OHM THEREFORE THE ABLATION COULD NOT BE CONDUCTED WHEN THE CATHETER WAS INSERTED INTO THE CARDIAC CAVITY AFTER CONNECTING IT TO THE PATIENT INTERFACE UNIT (PIU). THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND RING 1 PROXIMAL SIDE HAD GREENISH MATERIAL. FOLLOW UP WAS MADE WITH THE AFFILIATE; HOWEVER, THIS CONDITION WAS NOT NOTICED BY THE CUSTOMER. AT THIS TIME THE ORIGIN OF THE MATERIAL COULD NOT BE DETERMINED SINCE THIS CONDITION WAS NOT OBSERVED BY THE ACCOUNT AND IT IS NOT LIKELY RELATED WITH THE MANUFACTURING PROCESS. IN ADDITION, REDDISH MATERIAL WAS ALSO OBSERVED BUT IT WAS THE COPPER LEAD WIRE THAT IS WELDED TO RING 1 AND IT CAN BE VISUALIZED SINCE A PORTION OF IT HAS TO BE OUT OF THE PEEK HOUSING (PER CATHETER DESIGN). ADDITIONALLY, THE COPPER LEAD WIRE WAS STILL PROPERLY COVERED WITH POLYURETHANE (ADHESIVE). THEN PER THE REPORTED EVENT, CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, STOCKERT COMPATIBILITY AND THERMAL SENSOR RESPONSE. THE CATHETER FAILED ON RING 1. FURTHER INVESTIGATION REVEALED THAT THE LEAD WIRE OF RING 1 WAS NOT MAKING PROPER CONTACT WITH THE ELECTRODE ITSELF. NONETHELESS, THE TIP DOME, WHICH IS IN CHARGE OF MEASURING THE IMPEDANCE, WAS PROPERLY WORKING 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 REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE TIP DOME WAS PROPERLY WORKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN EZ STEER THERMOCOOL NAVIGATIONAL 4MM CATHETER. THE BWI FAILURE ANALYSIS LAB NOTED THE RETURNED PRODUCT CONDITION OF THE PROXIMAL SIDE OF THE ELECTRODE RING #1 HAD A COPPER LEAD WIRE EXPOSED. IT WAS ORIGINALLY REPORTED THE IMPEDANCE OF THE EZ STEER THERMOCOOL NAVIGATIONAL 4MM CATHETER WAS DISPLAYING AROUND 900OHM THEREFORE THE ABLATION COULD NOT BE CONDUCTED WHEN THE CATHETER WAS INSERTED INTO THE CARDIAC CAVITY AFTER CONNECTING IT TO THE PATIENT INTERFACE UNIT (PIU). THE CABLE WAS CHANGED AND RECONNECTED BUT THE ISSUE CONTINUED. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE EVENT WAS ORIGINALLY ASSESSED AS NOT REPORTABLE BECAUSE THE HIGH IMPEDANCE DISABLED THE ABILITY TO ABLATE. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON (B)(4) 2014, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE PROXIMAL SIDE OF THE ELECTRODE RING #1 HAD A COPPER LEAD WIRE EXPOSED CAUSING LIGHT GREEN MATERIAL ON THE ELECTRODE RING AND WIRE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE; HOWEVER, BWI BECAME AWARE OF THE RETURNED PRODUCT CONDITION ON (B)(4) 2014 AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE HAS BEEN RESET TO (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750987 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 16045656M

    Patients

    Seq Age Sex Outcome Treatment
    1