BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN COACCESS NEEDLE ELECTRODE

    MDR report key: 1062030 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00729
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS CANNOT BE PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008 15-MONTH COMPLAINT TREND REPORT FOR THE RF PROBE PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS NEEDLE ELECTRODE DEVICE WAS INTENDED TO BE USED DURING A RADIOFREQUENCY ABLATION PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, "IT WAS NOTED THAT THE INTRODUCER HAS SOME TEAR AND FLARED AT THE TIP." REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (PRODUCT UNKNOWN) AND THERE WERE NO PT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN COACCESS NEEDLE ELECTRODE JOS BOSTON SCIENTIFIC CORPORATION M001262230 8084923

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK