BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2 GUIDEWIRE

    MDR report key: 1073718 · Received July 1, 2008

    Report

    Report Number
    2939204-2008-00265
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A DILATATION PROCEDURE WAS PERFORMED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), IN WHICH A BALLOON AND A GUIDEWIRE (SUSPECT DEVICE) WERE USED. IT WAS REPORTED THE PHYSICIAN HAD EXPERIENCED SOME FRICTION WITH THE GUIDEWIRE WHILE CROSSING THE LESION. THEREFORE, THE GUIDEWIRE AND BALLOON WERE REMOVED. THE GUIDEWIRE WAS WASHED WITH SALINE AND COATING WAS NOTED TO BE PEELING OFF ABOUT 100 CM FROM THE DISTAL TIP. IT IS UNK WHEN THE COATING HAD PEELED OFF. HOWEVER, IT WAS REPORTED "NO FOREIGN MATERIAL WAS FOUND WHEN LUMEN OF THE GUIDING CATHETER AND WIRE LUMEN OF THE BALLOON WERE CHECKED DURING PREPARATION. BEFORE CLOSING THE PROCEDURE, IMAGING CHECK WAS PERFORMED AT BRAIN ARTERIES AND NO ANOMALIES WERE FOUND." PT CONDITION IS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2 GUIDEWIRE NEURO GUIDEWIRE DQX DQX BOSTON SCIENTIFIC CORP. 1351 B11159

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER (MODEL & MFR UNK)