BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSURE GUIDEWIRE

    MDR report key: 3944580 · Received July 14, 2014

    Report

    Report Number
    MW5037282
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    VOLCANO
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EXAM WAS PERFORMED EXPLICITLY FOR PRESSURE MEASUREMENTS TO DETERMINE BYPASS NUMBER. PRESSURE WIRE WAS INSERTED AND ATTEMPTED TO CONTINUE WITH READINGS. WHEN REMOVING WIRE, IT CAUGHT ON PREVIOUSLY IMPLANTED STENT IN WHICH SHE WAS GOING TO HAVE BYPASSED WITH PRESSURE READINGS. WIRE AND MECHANISM WAS SEPARATED AND OUTER WRAPPED WIRE SEPARATED AND IS STILL CAUGHT INSIDE OF LEFT MAIN CORONARY ARTERY. PT WENT STRAIGHT TO BYPASS. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: PRESSURE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410126 VERRATA PRESSURE GUIDEWIRE GUIDEWIRE DQX VOLCANO 10185 0243500133310034

    Patients

    Seq Age Sex Outcome Treatment
    1