BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PLAQUE EXCISION SYSTEM

    MDR report key: 1911732 · Received November 23, 2010

    Report

    Report Number
    2183870-2010-00184
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    May 17, 2010
    Report Date
    November 9, 2010
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THIS PROCEDURE IS PART OF THE DEFINITIVE LE TRIAL. DURING AN ATHERECTOMY PROCEDURE, AN ARTERIAL PERFORATION WAS REPORTED. ANGIOPLASTY WAS UTILIZED TO TREAT THE PERFORATION AND IT WAS RESOLVED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK PLAQUE EXCISION SYSTEM MCW EV3 INC. THS-LS-C 7819684

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention