BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME WIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 2022023 · Received March 1, 2011

    Report

    Report Number
    2022023
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    VOLCANO CORP.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PRIME WIRE CONNECTION WAS NOT BEING SENSED. THE PRIME WIRE WAS ZEROED IN THE HOOP. A MESSAGE APPEARED ON THE SCREEN THAT THE WIRE NEEDED TO BE CONNECTED, EVEN THOUGH THE PRIME WIRE WAS NEVER DISCONNECTED, THE MESSAGE STILL BLINKED ON/OFF. THE PRIME WIRE WAS REATTACHED AND STILL GOT SIGNAL THAT WIRE NEEDED TO BE CONNECTED. SO A NEW WIRE WAS USED AND WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIME WIRE PRESTIGE PRESSURE GUIDE WIRE PRESSURE WIRE DQX VOLCANO CORP. 7903 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *