BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3102506 · Received May 9, 2013

    Report

    Report Number
    2183870-2013-00111
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 3, 2013
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS ATHERECTOMY ON THE RIGHT LOWER EXTREMITY. THE TURBOHAWK WOULD NOT CROSS THE LESION TO THE TPT. THE PHYSICIAN PREDILATED AND IT STILL WOULD NOT CROSS. EVALUATION OF THE RETURNED DEVICE FOUND A STAINLESS STEEL STENT TRAPPED IN THE DISTAL TIP ASSEMBLY'S HOUSING. THE STENT HAD BEEN TRAPPED BETWEEN THE CUTTER HEAD ASSEMBLY AND THE HOUSING WINDOW'S DISTAL EDGE NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204192 TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-SX-C 9693036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other