BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO VISIONS PV .035 CATHETER

    MDR report key: 8101644 · Received November 23, 2018

    Report

    Report Number
    MW5081567
    Event Type
    Malfunction
    Date Received
    November 23, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 21, 2018
    Manufacturer
    VOLCANO CORP.
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VOLCANO CATHETER MALFUNCTIONED DURING SURGERY. PER MD THE IMAGE SHOWED A WEDGE ABOUT 1/3 THE SIZE OF THE IMAGE CIRCLE. ONCE THE CATHETER WAS SWITCHED OUT, THE IMAGE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938625 VOLCANO VISIONS PV .035 CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORP. 0301545165

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR