BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBOHAWK

    MDR report key: 3896659 · Received June 20, 2014

    Report

    Report Number
    3896659
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    EV3, INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    TURBOHAWK LS-C PACKAGING STATED THAT MINIMUM SHEATH SIZE IS 7 FR. WE USED A 7 FR DESTINATION SHEATH AND THE DEVICE WAS TOO TIGHT TO PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363396 TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3, INC. THS-LS-C 9795714

    Patients

    Seq Age Sex Outcome Treatment
    1 *
    2 *