BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    MDR report key: 1964250 · Received January 19, 2011

    Report

    Report Number
    2183870-2011-00011
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 27, 2010
    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 MANUFACTURING RECORDS 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 STUDY: DURING THE PROCEDURE POST TURBOHAWK, IT WAS NOTED THAT PATIENT HAD SMALL DISSECTION AT DISTAL END OF THE LESION. THE DISSECTION WAS TREATED EFFECTIVELY WITH ANGIOPLASTY AND THE DISSECTION WAS RESOLVED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK¿ PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-LS-C 7884172

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention