BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3062306 · Received April 16, 2013

    Report

    Report Number
    9673241-2013-00111
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE ULTRASOUND IMAGES OF LEFT ATRIUM WERE GENERATED, AND BROCKENBROUGH (BB) WAS CONDUCTED. A LASSO CATHETER WAS PLACED AT THE LEFT PULMONARY VEIN AFTER MERGE. THEN PULMONARY VEIN ISOLATION STARTED FROM THE LEFT POSTERIOR WALL AND THE THERMOCOOL CATHETER WAS DISPLAYING AN UNUSUAL LOW TEMPERATURE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. THE CUSTOMER COMPLAINT CANNOT BE 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE ULTRASOUND IMAGES OF LEFT ATRIUM WERE GENERATED, AND BROCKENBROUGH (BB) WAS CONDUCTED. A LASSO CATHETER WAS PLACED AT THE LEFT PULMONARY VEIN AFTER MERGE. THEN PULMONARY VEIN ISOLATION STARTED FROM THE LEFT POSTERIOR WALL AND THE THERMOCOOL CATHETER WAS DISPLAYING AN UNUSUAL LOW TEMPERATURE. IT WAS 32-33 ° C INSIDE THE CARDIAC CAVITY AND 36-37 ° C DURING ABLATION AT 20-30 W. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER. AFTER THIS CHANGE, THE TEMPERATURE WAS 35-36 ° C INSIDE THE CARDIAC CAVITY AND 38-41 ° C DURING ABLATION. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION ABOUT THE EVENT IT WAS CONFIRMED THAT THE IMPROPER TEMPERATURE READINGS WERE NOTICED WHILE RF WAS APPLIED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162288 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 15776154M

    Patients

    Seq Age Sex Outcome Treatment
    1