BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1494512 · Received August 18, 2009

    Report

    Report Number
    2939204-2009-00697
    Event Type
    Malfunction
    Date Received
    August 18, 2009
    Date of Event
    July 24, 2009
    Report Date
    July 31, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL: PMA/510 (K): K002907.

    Description of Event or Problem · 1

    AFTER AN UNSUCCESSFUL ATTEMPT TO ADVANCE THE GUIDEWIRE (SUBJECT DEVICE) THROUGH THE MICROCATHETER, THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT. THE DEVICE WAS VISUALLY INSPECTED AFTER REMOVING FROM THE PATIENT, AND "IRREGULAR BUMPS" WERE NOTED ON THE MIDDLE SECTION OF THE DEVICE, WHICH WERE NOT OBSERVED DURING THE INITIAL INSPECTION OF THE DEVICE. "IRREGULAR BUMPS" LOOKED LIKE "COATING COMING OFF THE WIRE AND THERE WERE CERTAIN PORTION THAT IS NOT THE SAME COLOR AS THE ENTIRE WIRE." THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT AND THE PATIENT WAS REPORTEDLY IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION M00313020 B15785

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC).