BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3103035 · Received May 9, 2013

    Report

    Report Number
    2183870-2013-00113
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    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 MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER IS CURRENTLY UNKNOWN. THE LOT NUMBER OF THE DEVICE HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4), 2013 THE LOT NUMBER FOR THIS DEVICE WAS RECEIVED. 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

    ON (B)(6) 2013, THE PROCEDURE WAS ATHERECTOMY OF HEAVY CALCIUM IN THE R CFA AND R SFA. TWELVE PLANES OF ATHERECTOMY WERE COMPLETED. UPON REMOVAL, DUE TO THE CALCIFIC AND RIGID NATURE OF THE VESSEL, A PORTION OF THE TURBOHAWK COLLECTING CHAMBER TIP (APPROX 1CM) WAS SHEARED OFF ON THE PLAQUE OR THE SHEATH. THIS WAS ATTEMPTED TO BE REMOVED BY SNARE BUT AS IT WAS IN A SIDE BRANCH OF THE INTERNAL ILIAC ARTERY AND IN A STABLE/INNOCUOUS POSITION. IT WAS LEFT FOR RETRIEVAL AT A LATER DATE. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE PIECE OF DEVICE. THE PATIENT WAS BROUGHT BACK FOR REMOVAL OF DEVICE ON (B)(6) 2013. Y. EVALUATION OF THE RETURNED DEVICE INDICATES THE TIP OF THE TURBOHAWK DETACHED AS A RESULT OF WITHDRAWING THE TURBOHAWK DEVICE THROUGH THE GUIDE SHEATH OVER A PROLAPSED OR COILED GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203364 TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-LS-C 9644287

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 7F BALKAN COOK SHEATH