BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONS PV .014

    MDR report key: 2201387 · Received August 3, 2011

    Report

    Report Number
    2939520-2011-00052
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER SO A DEVICE EVALUATION HAS NOT BEEN PERFORMED YET. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN FELT RESISTANCE WHEN THE CATHETER WAS LOADED INTO THE GUIDEWIRE AND THE TIP OF THE GUIDEWIRE COULD NOT COME OUT THROUGH THE EXIT PORT. THE CATHETER WAS FLUSHED AGAIN; HOWEVER, THE SAME PROBLEM OCCURRED. ANOTHER DEVICE (DETAILS UNKNOWN AS OF THIS TIME) WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV .014 INTRAVASCULAR ULTRASOUND CATHETER IYO VOLCANO CORPORATION 063 01227

    Patients

    Seq Age Sex Outcome Treatment
    1