BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 910036 · Received March 9, 2007

    Report

    Report Number
    2954936-2007-00009
    Event Type
    Other
    Date Received
    March 9, 2007
    Date of Event
    February 9, 2007
    Report Date
    March 9, 2007
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Product Problem
    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

    DURING THE CASE, AN EMBOLIC EVENT SHUT DOWN A COLLATERAL FOR THE ANTERIOR TIBIAL. AFTER REMOVING THE DEVICE, IT WAS NOTED THAT THE DEVICE WAS NOT FLUSHING PROPERLY. CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    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. FG06800 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention