BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2933767 · Received January 29, 2013

    Report

    Report Number
    9673241-2013-00021
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY THIS EVENT WAS REPORTED UNDER THE CARTO 3 SYSTEM (REGULATORY REPORT #: 3008203003-2012-00059). AS NO PRODUCT WAS RETURNED AT THE TIME OF THE INITIAL REPORT, IT WAS DECIDED TO REPORT UNDER CARTO 3 SYSTEM SINCE THE SIGNAL LOSS ISSUE WAS MOST LIKELY RELATED TO THE CARTO 3 SYSTEM. THE REPAIR RECORDS FOR CARTO 3 SYSTEM INDICATED THAT THE SYSTEM WAS FUNCTIONAL, ALTHOUGH THE ECG CARDS AND THE ECG QUICK CONNECT CABLE WERE REPLACED PER PHYSICIAN REQUEST. HOWEVER, FURTHER INVESTIGATION INDICATED THAT THE NAVI-STAR THERMO-COOL CATHETER MIGHT BE RELATED TO THE COMPLAINT ISSUE BASED ON FAILURE ANALYSIS FINDINGS ON (B)(4) 2013 DATING THIS AS ALERT DATE. (B)(4). THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, STOCKERT COMPATIBILITY AND THERMAL SENSOR RESPONSE. THE CATHETER FAILED ELECTRICAL TEST DUE TO CORROSION FOUND IN THE PC BOARD, CONNECTOR AND WIRES. THE COMPLAINT CONDITION WAS CONFIRMED. THE DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A PAROXYSMAL A-FIB PROCEDURE, AFTER MAPPING AND ABLATING DURING THE CASE, THE CARTO 3 SYSTEM DISPLAYED ARTIFACT ON THE MAP SIGNALS, THEN INTERMITTENT ARTIFACT ON ALL SIGNALS, BS SIGNALS WERE LOST FOLLOWED BY ALL SIGNALS LOST. PRIOR TO REPORT THIS ISSUE, THE PHYSICIAN REBOOTED SYSTEM WITHOUT CATHETERS CONNECTED TO PIU. ONCE THAT THE MAPPING CATHETER WAS CONNECTED, THE ARTIFACT RETURNED. EXCHANGING REDEL, MAP CABLES AND MAP CATHETER WITHOUT RESOLUTION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT THE SIGNAL LOSS OCCURRED ON BOTH CARTO AND EP RECORDING SYSTEMS AT THE SAME TIME. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A BLAZER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38884 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-15-S 15681497M

    Patients

    Seq Age Sex Outcome Treatment
    1