BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER? NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3243749 · Received July 23, 2013

    Report

    Report Number
    9673241-2013-00252
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P010068/S6
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE TIP HAD CHAR. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. SINCE THE CATHETER PASSED SPECIFICATIONS, THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN.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 DURING AN ATRIAL FLUTTER (AFL) PROCEDURE, THERE WERE NO INTRACARDIAC SIGNALS ON THE CATHETER. THE CABLES WERE EXCHANGED WITHOUT SUCCESS. THE CATHETER WAS EXCHANGED AND THE CASE RESUMED WITHOUT PATIENT CONSEQUENCES. THE PRODUCT WAS RECEIVED IN THE LAB ON (B)(4) 2013 FOR ANALYSIS AND IT WAS FOUND THAT THE CATHETER HAD CHAR ON THE TIP SECTION MAKING THIS EVENT REPORTABLE. AWARENESS DATE CHANGED TO (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343734 EZ STEER? NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1260-04-S 15786439M

    Patients

    Seq Age Sex Outcome Treatment
    1