BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PLUS PRESSURE GUIDE WIRE

    MDR report key: 2854426 · Received November 29, 2012

    Report

    Report Number
    2939520-2012-00071
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K111395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER SO A DEVICE EVALUATION HAS NOT BEEN PERFORMED YET. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE GUIDEWIRE WAS SUCCESSFULLY ZEROED AND INSERTED INTO THE PATIENT ONCE. WHEN THE PRESSURE GUIDEWIRE WAS EXITING THE GUIDE CATHETER, THE PHYSICIAN NOTICED BY ANGIOGRAPHY THAT THE COIL OF THE RADIOPAQUE PORTION OF THE WIRE WAS UNRAVELED; APPEARED TO HAVE BEEN "PULLED" OR "UNCOILED". THE WIRE WAS IMMEDIATELY REMOVED AND A NEW WIRE WAS SUCCESSFULLY USED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MID LAD LESION, APPROXIMATELY 65% STENOSIS; TUBULAR LESION. THERE WAS NO PATIENT INJURY AND ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESTIGE PLUS PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 9185J 111 01119

    Patients

    Seq Age Sex Outcome Treatment
    1