BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ SX-C PLAQUE EXCISION SYSTEM

    MDR report key: 2063699 · Received April 20, 2011

    Report

    Report Number
    2183870-2011-00070
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TURBOHAWK THS-SS-CL WAS PASSED OVER A WIRE INTO THE POSTERIOR TIBIAL ARTERY. ONE PASS WAS MADE AND AN ANGIO WAS THEN TAKEN AND THERE WAS A SMALL STAIN IN THE AREA OF TREATMENT. A 2.5MM ARTERY BALLOON WAS THEN INFLATED IN THE SAME LOCATION. AFTER THE BALLOON WAS DEFLATED, POST ANGIO WAS TAKEN AND THERE WAS NO STAINING LEFT AND THE VESSEL LOOKED VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK¿ SX-C PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-SS-CL 9408779

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PT FLOPPY WIRE