BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® SXL PLAQUE EXCISION SYSTEM

    MDR report key: 1982658 · Received February 9, 2011

    Report

    Report Number
    2183870-2011-00021
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 11, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN COULD NOT ADVANCE THE SILVERHAWK THROUGH THE POPLITEAL. DURING THE PLANNED LEFT AT ATHERECTOMY, VIA RIGHT FEMORAL ACCESS, A POSSIBLE DISSECTION WAS NOTED. THE DEVICE WAS RETRIEVED VIA SNARE. NO INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® SXL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. P4033 9380367

    Patients

    Seq Age Sex Outcome Treatment
    1 0.014 CHOICE POINT WIRE| 6F BALKIN SHEATH