BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 810201 · Received October 27, 2006

    Report

    Report Number
    2954936-2006-00075
    Event Type
    Malfunction
    Date Received
    October 27, 2006
    Date of Event
    October 4, 2006
    Report Date
    October 25, 2006
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 MAY 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

    REPORTED AS: PHYSICIAN WRAPPED THE GUIDEWIRE AROUND THE NOSECONE AND SEPARATED IT FROM THE SHAFT. NOSECONE REMAINED ON THE GUIDEWIRE AND WAS RETRIEVED WITHOUT ANY COMPLICATIONS.

    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 06071310

    Patients

    Seq Age Sex Outcome Treatment
    1 *