BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 819088 · Received February 15, 2007

    Report

    Report Number
    2954936-2007-00001
    Event Type
    Other
    Date Received
    February 15, 2007
    Date of Event
    December 4, 2006
    Report Date
    January 2, 2007
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    AV FISTULA FORMED IN PATIENT'S CALF, POST SILVERHAWK PROCEDURE. MD RESOLVED BY REVERSING ANTI-PLATELETS AND WRAPPING THE LEG. PATIENT DISCHARGED WITHOUT FURTHER COMPLICATION IN 12/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM PERIPHERAL ATHERECTOMY CATHETER MCW FOX HOLLOW TECHNOLOGIES, INC. FG04706 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention