BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK PERIPHEREAL PLAQUE EXCISION SYSTEM

    MDR report key: 789743 · Received November 22, 2006

    Report

    Report Number
    2954936-2006-00078
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    August 21, 2006
    Report Date
    November 22, 2006
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.,
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. SUSPECTED PROBLEM INDENTIFIED IN RESULTS AND CONCLUSIONS. ADDITIONAL 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 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: SS DEVICE NOSECONE BROKE OFF ONTO THE WIRE. NOSECONE WAS MANEUVERED INTO THE SHEATH AND THE SHEATH WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK PERIPHEREAL PLAQUE EXCISION SYSTEM PERIPHERAL ATHERECTOMY CATHETER MCW FOX HOLLOW TECHNOLOGIES, INC., P4020 06050906

    Patients

    Seq Age Sex Outcome Treatment
    1 *