BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO²¿

    MDR report key: 2822521 · Received November 7, 2012

    Report

    Report Number
    2939204-2012-00344
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS NOTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS FLAKING OFF THE GUIDEWIRE PROXIMAL SHAFT AND THE GUIDEWIRE WAS PULLED OUT OF THE MICROCATHETER BEFORE INSERTION INTO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M00326110 B23883

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR EXCELSIOR SL10 MICROCATHETER (BOSTON SCIENTIFIC)