BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 855997 · Received May 24, 2007

    Report

    Report Number
    2954936-2007-00011
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 14, 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

    ADD'L INFO: REFERENCE IFU FOR APPROPRIATE WARNING REGARDING WIRE PROLAPSE. WARNING: NEVER ADVANCE THE DISTAL TIP OF THE CATHETER NEAR THE FLOPPY END OF THE GUIDEWIRE. A CATHETER ADVANCED TO THIS POSITION MY NOT FOLLOW THE GUIDEWIRE WHEN IT IS RETRACTED AND CAUSE THE GUIDEWIRE TO BUCKLE INTO A LOOP. IF THIS OCCURS, CATHETER AND GUIDEWIRE SHOULD BE REMOVED TOGETHER TO PREVENT POTENTIAL DAMAGE TO VESSEL WALLS. IF RESISTANCE IS STILL FELT, THE SHEATH SHOULD ALSO BE REMOVED AS PART OF THE UNIT.

    Description of Event or Problem · 1

    CATHETER TIP SEPARATED UPON REMOVING FOR CLEANING. THE TIP WAS RETRIEVED.

    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. P4028 07010508

    Patients

    Seq Age Sex Outcome Treatment
    1 YR