BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK

    MDR report key: 2760171 · Received January 29, 2007

    Report

    Report Number
    2760171
    Event Type
    Malfunction
    Date Received
    January 29, 2007
    Date of Event
    January 24, 2007
    Report Date
    January 25, 2007
    Manufacturer
    FOXHOLLOW
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE MS ARTHRECTOMY DEVICE FROM THE ARTERY, THE BASE OF THE CATHETER COMPONENTS FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK ATHRECTOMY CATHETER MCW FOXHOLLOW P4016 06101011

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR