BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2881546 · Received December 20, 2012

    Report

    Report Number
    9673241-2012-00375
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE PROCEDURE, IT WAS OBSERVED THE IMPEDANCE WAS ABNORMAL. THE SIGNALS HAD INTERFERENCE/NOISE. THE TEMPERATURE WAS TOO LOW. ADDITIONAL INFORMATION STATED THE PHYSICIAN WAS UNABLE TO INTERPRET EITHER THE BODY SURFACE ECGS NOR THE INTRACARDIAC SIGNALS. CATHETER WAS REPLACED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT CONSEQUENCE. UPON RECEIPT THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITION. THE RETURNED DEVICE WAS TESTED FOR ELECTRICAL PERFORMANCE, STOCKERT COMPATIBILITY AND THERMAL SENSOR RESPONSE. THE CATHETER FAILED ELECTRICAL TEST. FURTHER INVESTIGATION REVEALED THAT THE DOME LEAD WIRE HAD A SHORT. FURTHERMORE, THE CATHETER WAS TESTED FOR EEPROM AND CALIBRATION FUNCTIONALITY. THE CATHETER FAILED DURING CALIBRATION FUNCTIONALITY TEST. FURTHER EXAMINATION SHOWED THAT THE SENSOR WAS WITHIN SPECIFICATIONS. ACCORDING TO THE CALIBRATION RESULTS AND THE SENSOR READINGS, THE IMPROPER CONDITION WAS ATTRIBUTED TO AN INTERNAL PC BOARD FAILURE. 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. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS OBSERVED THE IMPEDANCE WAS ABNORMAL. THE SIGNALS HAD INTERFERENCE/NOISE. THE TEMPERATURE WAS TOO LOW. ADDITIONAL INFORMATION STATED THE PHYSICIAN WAS UNABLE TO INTERPRET EITHER THE BODY SURFACE ECGS NOR THE INTRACARDIAC SIGNALS. CATHETER WAS REPLACED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-14-S 15598765M

    Patients

    Seq Age Sex Outcome Treatment
    1