BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK

    MDR report key: 668104 · Received January 12, 2006

    Report

    Report Number
    668104
    Event Type
    Malfunction
    Date Received
    January 12, 2006
    Date of Event
    December 30, 2005
    Report Date
    January 11, 2006
    Manufacturer
    FOX HOLLOW TECHNOLOGIES, INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON ATTEMPTING TO REMOVE THE LS SILVERHAWK CATHETER, THE SURGEON MET WITH RESISTANCE ON COMING OVER THE ILIAC BIFURCATION. IMAGING OF THIS SHOWED THE WIRE TO BE TWISTED AROUND THE CATHETER. THE SURGEON DID NOT SEE THIS HAPPENING DURING THE REMOVAL, BUT IT CAUGHT THE CATHETER ON THE SHEATH AND FOR SAFETY REASONS, THE SURGEON REMOVED THE ENTIRE DEVICE (CATHETER WITH WIRE AND SHEATH). THERE WAS NO EMBOLIZATION AND NO EVIDENCE OF INJURY TO THE VESSEL FROM THE DISRUPTED DEVICE. PROCEDURE COMPLETED WITH ANOTHER CATHETER AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK ATHERECTOMY CATHETER MCW FOX HOLLOW TECHNOLOGIES, INC. P4012 05092712

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR