BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK PLAQUE EXCISION CATHETER SYSTEM

    MDR report key: 1027937 · Received April 10, 2008

    Report

    Report Number
    2954936-2008-00055
    Event Type
    Injury
    Date Received
    April 10, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 9, 2008
    Manufacturer
    FOX HOLLOW TECHNOLOGIES
    Product Code
    MCW
    PMA / PMN Number
    K061188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN MADE 1 INSERTION AND 9 PASSES IN A HEAVILY CALCIFIED LESION. ARTERY WAS PERFORATED WITH 1ST DEVICE. PT IS DOING FINE. THE PERFORATION WAS VERY SMALL AND RESOLVED W/ANGIOPLASTY. PACKED NOSECONE CONTAINED CALCIUM THAT WAS SO DENSE AND IT WOULD NOT COMPLETELY CLEAN. ONE LARGE PIECE OF PLAQUE LODGED AT THE MOUTH OF THE CUTTER AND WOULD NOT COME OUT. A SECOND MS-M DEVICE WAS PULLED TO COMPLETE THE CASE. SECOND MS-M PACKED VERY EFFICIENTLY AND PERFORMED WELL.

    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 10504 08020703

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention