BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERHAWK PLAQUE EXCISION SYSTEM

    MDR report key: 696288 · Received April 4, 2006

    Report

    Report Number
    2954929-2006-00018
    Event Type
    Other
    Date Received
    April 4, 2006
    Date of Event
    March 1, 2006
    Report Date
    April 4, 2006
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) IN LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE ORIGINALLY PLACED BALKIN SHEATH REPLACED BY AN 8FR RAABE SHEATH WHICH WAS INSERTE FULLY SO THAT IT WAS WELL DOWN THE SFA AND NEAR THE PROXIMAL ASPECT OF THE LESION. A SILVERHAWK (P4012) LS DEVICE WAS THEN USED. THE PHYSICIAN SAID THE DEVICE PASSED THROUGH THE SHEATH WITH NO RESISTANCE AND AFTER 2 CUTS, RE-ENTERED THE SHEATH (WITHOUT ANGULATION) WITHOUT ANY RESISTANCE. TOTAL OF 8 CUTS, LOOKED REALLY GOOD EXCEPT FOR A SMALL FISTULA, REQUIRING A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK PLAQUE EXCISION SYSTEM PERIPHERAL ATHERCTOMY CATHETER MCW FOX HOLLOW TECHNOLOGIES, INC. 4800 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other