BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION

    MDR report key: 1289666 · Received December 9, 2008

    Report

    Report Number
    2939520-2008-00034
    Event Type
    Other
    Date Received
    December 9, 2008
    Date of Event
    May 9, 2008
    Report Date
    December 10, 2008
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSICAL INSPECTION OF THE DEVICE WAS PERFORMED BY A TEAM CONSISTING OF MANUFACTURING ENGINEERING, R&D, AND QA. THE DEVICE WAS VISUALLY INSPECTED AND THE PROXIMAL SHAFT WAS FOUND TO BE DAMAGED. A CAPACITANCE TEST WAS PERFORMED AND THE DEVICE PASSED. AN IMAGE TEST WAS PERFORMED AND AN IMAGE WAS PRODUCED. THERE WERE NO OBSERVED PROCESS OR WORKMANSHIP DEFECTS NOTED ON THE CATHETER. THERE IS NO OBSERVED EVIDENCE TO CONCLUDE THAT THE CATHETER IS OUT OF SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO NONCONFORMANCE THAT COULD HAVE LEAD TO THE REPORTED FAILURE. ALTHOUGH, THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS INCIDENT, IF THE EVENT WERE TO REOCCUR, THERE COULD BE A POTENTIAL FOR INJURY. THIS REPORT IS BEING SENT AS A NOTIFICATION.

    Description of Event or Problem · 1

    THE CATHETER SHAFT WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 89000 035-01574

    Patients

    Seq Age Sex Outcome Treatment
    1