BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERRATA PRESSURE GUIDE WIRE

    MDR report key: 3966522 · Received July 25, 2014

    Report

    Report Number
    MW5037487
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 17, 2014
    Manufacturer
    VOLCANO CORP.
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT IN FOR ELECTIVE CARDIAC CATHETERIZATION. DURING THE PROCEDURE, A VOLCANO VERRATA PRESSURE GUIDE WIRE WAS INSERTED WITHOUT DIFFICULTY. WHEN ATTEMPTING TO MOVE THE WIRE INTO POSITION, THE WIRE BECAME STUCK; THE PHYSICIAN WAS UNABLE TO PULL BACK OR ADVANCE THE WIRE. SEVERAL MANEUVERS WERE ATTEMPTED BEFORE THE WIRE WAS DISLODGED. HOWEVER, IN THE INTERIM, THE ARTERY WAS DISSECTED. REPAIR WAS EVENTUALLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436555 VERRATA PRESSURE GUIDE WIRE VOLCANO VERRATA DXO VOLCANO CORP. 10300J

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| O| R