BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2/14 GUIDEWIERE

    MDR report key: 1193126 · Received October 7, 2008

    Report

    Report Number
    2939204-2008-00445
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Report Date
    September 15, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PRIOR TO USING THE GUIDEWIRE, IT WAS PREPARED AND FLUSHED WITH SALINE. UPON FLUSHING, THE USER OBSERVED COATING PARTICLES IN THE FLUSH LIQUID. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2/14 GUIDEWIERE (DQX) GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. 2641 B13910

    Patients

    Seq Age Sex Outcome Treatment
    1