BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION

    MDR report key: 1289664 · Received December 9, 2008

    Report

    Report Number
    2939520-2008-00033
    Event Type
    Other
    Date Received
    December 9, 2008
    Date of Event
    September 18, 2007
    Report Date
    December 10, 2008
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AT VOLCANO IN DAMAGED CONDITION, UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE DAMAGE.

    Description of Event or Problem · 1

    CATHETER SHAFT SPLIT AFTER SIMULATED CASE. NOT USED IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 89000 035-01268

    Patients

    Seq Age Sex Outcome Treatment
    1