BEUDAMED
    FDA Adverse Event Summary report: N

    SILVERHAWK XLV - REFORM

    MDR report key: 509302 · Received January 27, 2004

    Report

    Report Number
    2954929-2004-00001
    Date Received
    January 27, 2004
    Date of Event
    December 16, 2003
    Report Date
    January 14, 2004
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN MADE SEVERAL CUTTING PASSES. WHILE ATTEMPTING TO REMOVE DEVICE IT FELT LIKE IT CAUGHT ON SOMETHING, PERHAPS EDGE OF SHEATH, AND THE TIP DETATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK XLV - REFORM PERIPHERAL ATHERECTOMY CATHETER MCW FOX HOLLOW TECHNOLOGIES, INC. 04200 03120802

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention