BEUDAMED
    FDA Adverse Event Other Summary report: N

    REFORM/SILVERHAWK CATHETER SYSTEM

    MDR report key: 542574 · Received September 2, 2004

    Report

    Report Number
    2954929-2004-00008
    Event Type
    Other
    Date Received
    September 2, 2004
    Date of Event
    July 22, 2004
    Report Date
    August 22, 2004
    Manufacturer
    FOX HOLLOW TECHNOLOGIES INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "PUSHED THE CATHETER FORWARD, DEVICE GOT STUCK IN STENT. SPENT 4-5 HOURS TRYING TO TWIST THE DEVICE OUT. NOT SUCCESSFUL. SENT PT TO SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFORM/SILVERHAWK CATHETER SYSTEM ATHERECTOMY CATHETER MCX FOX HOLLOW TECHNOLOGIES INC. 4200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention