BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 2657344 · Received July 10, 2012

    Report

    Report Number
    2939520-2012-00044
    Event Type
    Malfunction
    Date Received
    July 10, 2012
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    VOLCANO CORP
    Product Code
    DQX
    PMA / PMN Number
    K100930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THAT RESISTANCE WAS FELT WHEN THE BALLOON CATHETER WAS BEING LOADED ON THE GUIDEWIRE. THE GUIDEWIRE WAS REMOVED WITH THE BALLOON CATHETER, AND IT WAS FOUND THAT THE GUIDEWIRE WAS STRETCHED. ALL PORTIONS OF THE GUIDEWIRE APPEARED TO BE ACCOUNTED FOR WHEN IT WAS REMOVED FROM THE CATHETER. IT WAS REPORTED THAT THE GUIDEWIRE TIP WAS SHAPED; HOWEVER, IT WAS UNK WHAT TYPE OF TOOL WAS USED FOR SHAPING. THE LESION CHARACTERISTICS ARE UNK. THE PROCEDURE WAS COMPLETED WITH THE NEW GUIDEWIRE OF THE SAME MODEL. THERE WAS NO PT INJURY AND NO ADVERSE EVENTS REPORTED. THIS IS BEING REPORTED AS A NOTIFICATION ONLY. IT IS VOLCANO'S POLICY TO REPORT ALL CASES WHERE A POTENTIAL VOLCANO DEVICE ISSUE CAUSES REMOVAL OR EXCHANGE OF THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORP 8185 114 03153

    Patients

    Seq Age Sex Outcome Treatment
    1