BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .010" SILVERSPEED HYDROPHILIC GUIDEWIRE

    MDR report key: 2010304 · Received March 8, 2011

    Report

    Report Number
    2029214-2011-00051
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION, IT WAS REPORTED THAT THE GUIDEWIRE WAS PLACED IN A SALINE TRAY AND THE PHYSICIAN FOUND SMALL COATING SUBSTANCES FLOATING IN THE TRAY. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .010" SILVERSPEED HYDROPHILIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0602-200 9265316

    Patients

    Seq Age Sex Outcome Treatment
    1