BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2471465 · Received February 28, 2012

    Report

    Report Number
    2183870-2012-00038
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    November 2, 2010
    Report Date
    February 9, 2012
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 WAS REQUESTED. SHOULD WE RECEIVE THE INFORMATION A SUPPLEMENTAL REPORT WILL BE SENT. DEVICE DISCARDED AT HOSPITAL.

    Description of Event or Problem · 1

    POST PROCEDURE THE PATIENT DEVELOPED A 9CM PSEUDO ANEURISM WHICH HAD TO BE SURGICALLY TREATED. A COVERED STENT WAS PLACED BY A VASCULAR SURGEON AT A DIFFERENT HOSPITAL. THE PATIENT ALSO DEVELOPED A STAPH INFECTION WITH POSITIVE BLOOD CULTURES. WOUND SITE WAS CLEAN POST PROCEDURE. THE PROCEDURE WAS PERFORMED (B)(6), 2010, BUT WAS NOT REPORTED TO EV3 UNTIL (B)(6), 2012.

    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 9378974

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 6X150 PROTEGE EVERFLEX| PERCLOSE DEVICE| 7F TERUMO SHEATH| 6X15 VIABAHN STENT| 6X100 ABSOLUT