BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION

    MDR report key: 1306491 · Received February 5, 2009

    Report

    Report Number
    2939520-2009-00004
    Event Type
    Other
    Date Received
    February 5, 2009
    Date of Event
    December 24, 2008
    Report Date
    February 4, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED AS MDR REPORTABLE (B) (6) 2009 UPON INITIAL EVALUATION. (B) (4). THE CATHETER WAS ANALYZED AND INSPECTED UPON RECEIPT, THE CATHETER WAS INTACT, AND NO DAMAGE WAS FOUND. MANUFACTURING INFORMATION AND PREVIOUS COMPLAINT DATA WAS REVIEWED AGAINST THE LOT NUMBER, AND NO IRREGULARITIES WERE FOUND. NO EVIDENCE WAS SEEN THAT WOULD CONCLUDE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IN THE PAST, A SEVERELY KINKED GUIDE WIRE (AS WAS FOUND IN THIS CASE) HAS BEEN FOUND TO BE ATTRIBUTED TO THIS FAILURE MODE. 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. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT MULTIPLE RUNS OF THE LAD WERE PERFORMED; ON THE 3RD RUN, THE CATHETER DETACHED FROM THE WIRE AND WENT DOWN THE LCX. THE CATHETER AND WIRE WERE REMOVED AS A UNIT AND A NEW CATHETER WAS USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION INTRAVASCULAR ULTRASOUND CATHETER (IVUS) DQO VOLCANO CORPORATION 89000 035 02712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other