BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 769790 · Received October 11, 2006

    Report

    Report Number
    2954936-2006-00062
    Event Type
    Other
    Date Received
    October 11, 2006
    Date of Event
    June 14, 2006
    Report Date
    September 27, 2006
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. SUSPECTED PROBLEM IDENTIFIED IN RESULTS AND CONCLUSIONS. ADDITIONAL INFORMATION: 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: BROKEN NOSECONE, POSSIBLE WIRE WRAP. ADDITIONAL INFORMATION INDICATES THAT THE TIP BROKE OFF IN THE PATIENT. THE TIP ENDED UP IN THE PERONEAL, AND THE PHYSICIAN STENTED THE TIP IN ITS RESTING PLACE.

    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. P4024 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention