BEUDAMED
    FDA Adverse Event Other Summary report: N

    REFORM (SILVERHAWK) PERIPHERAL CATHETER

    MDR report key: 489998 · Received October 13, 2003

    Report

    Report Number
    2954929-2003-00004
    Event Type
    Other
    Date Received
    October 13, 2003
    Date of Event
    September 4, 2003
    Report Date
    October 2, 2003
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER 3 INSERTIONS OF THE FOX HOLLOW DEVICE, A PERFORATION WAS NOTED. THE PERFORATION WAS CONTROLLED USING BALLOON PRESSURE AND TREATED WITH 2 COVERED STENTS. PERFORATION ISSUE WAS RESOLVED. NO ALLEGED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFORM (SILVERHAWK) PERIPHERAL CATHETER ARTHERECTOMY MCX FOX HOLLOW TECHNOLOGIES, INC. 02200 03082001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention