BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 2011583 · Received March 9, 2011

    Report

    Report Number
    2939204-2011-00109
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    December 30, 2010
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS KINKED AND THE NITINOL SLEEVE WAS SEPARATED 8.7CM FROM THE DISTAL END. IT APPEARED THAT THE DEVICE KINKED AND THEN THE NITINOL SLEEVE SEPARATED. FROM THE CONDITION OF THE RETURNED DEVICE, IT IS MOST LIKELY THAT THE OBSERVED DAMAGES WERE CAUSED BY EXCESSIVE MANIPULATION DURING USE TO TREAT THE HIGHLY STENOSED LESION. THE DAMAGES ARE INDICATIVE THAT HIGH FRICTION WAS ENCOUNTERED BUT THE CAUSE OF THE FRICTION CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    ANALYSIS OF THE DEVICE FOUND THAT THE DISTAL END OF THE DEVICE HAD SEPARATED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY UNK174

    Patients

    Seq Age Sex Outcome Treatment
    1