BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    MDR report key: 2176410 · Received July 25, 2011

    Report

    Report Number
    2183870-2011-00142
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TIP OF THE TURBOHAWK THS-LX-C BROKE OFF IN PATIENT, BUT REMAINED ON THE WIRE. IT WAS A 4+ CALCIFIED VESSEL AND THE TIP WAS BOWING BEFORE IT DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK¿ PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-LX-C 9417204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7F DESTINATION SHEATH| SPIDERWIRE