BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3143474 · Received June 3, 2013

    Report

    Report Number
    9673241-2013-00177
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 5, 2013
    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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS NOISE IN POLYGRAPH SIGNAL. THE PLUGGED AND UNPLUGGED THE SYSTEM AND EVEN CHANGED THE CONNECTION CABLE DID NOT SOLVE THE ISSUE. ALSO THE SYSTEM INDICATED AN EEPROM ERROR IN THE CATHETER. BY REPLACING THE UNIT WITH SAME TYPE, THE ISSUE RESOLVED AND THE CASE COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. UPON FOLLOW UP, BIOSENSE WEBSTER RECEIVED THE INFORMATION ON (B)(6) 2013 (WHICH CHANGED THE ALERT DATE) THAT SHOWED THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. IT WAS NOT POSSIBLE TO DISTINGUISH THE NOISE OVER THE ELECTRIC SIGNAL OF THE HEART. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND CATHETER FAILED. FURTHER EXAMINATION SHOWED THAT THE CONNECTOR AND SOLDER JOINTS HAD CORROSION. FURTHERMORE, THE EEPROM WAS INTENDED TO BE READ, HOWEVER SINCE THE EEPROM DATA SHOWED AN ERROR, IT CAN BE DETERMINED THE EEPROM IS CORRUPTED. 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 CUSTOMER COMPLAINT HAS BEEN VERIFIED. HOWEVER, THE ROOT CAUSE OF THE CORRUPTED EEPROM REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS NOISE IN POLYGRAPH SIGNAL. THE PLUGGED AND UNPLUGGED THE SYSTEM AND EVEN CHANGED THE CONNECTION CABLE DID NOT SOLVE THE ISSUE. ALSO THE SYSTEM INDICATED AN EPROM ERROR IN THE CATHETER. BY REPLACING THE UNIT WITH SAME TYPE, THE ISSUE RESOLVED AND THE CASE COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. UPON FOLLOW UP, BIOSENSE WEBSTER RECEIVED THE INFORMATION ON (B)(4) 2013 (WHICH CHANGED THE ALERT DATE) THAT SHOWED THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. IT WAS NOT POSSIBLE TO DISTINGUISH THE NOISE OVER THE ELECTRIC SIGNAL OF THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243674 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S 15802310M

    Patients

    Seq Age Sex Outcome Treatment
    1