BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK PLAQUE EXCISION CATHETER SYSTEM

    MDR report key: 1020728 · Received March 26, 2008

    Report

    Report Number
    2954936-2008-00054
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    December 11, 2007
    Report Date
    March 13, 2008
    Manufacturer
    FOX HOLLOW TECHNOLOGIES
    Product Code
    MCW
    PMA / PMN Number
    K061188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: DEVICE NOT RETURNED TO MFR FOR EVAL. SUSPECTED PROBLEM IDENTIFIED IN RESULTS AND CONCLUSIONS.

    Description of Event or Problem · 1

    TWO PERFORATIONS OCCURRED WHILE USING THE SAME SILVERHAWK SX DEVICE (SAME PT). THEY WERE FOCAL PERFORATIONS AT THE MID PT AND PROXIMAL PT. NO IMPACT OR INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK PLAQUE EXCISION CATHETER SYSTEM PERIPHERAL ATHERECTOMY CATHETER MCW FOX HOLLOW TECHNOLOGIES FG 04706 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other