BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEERABLE GUIDE WIRE

    MDR report key: 20132 · Received March 3, 1995

    Report

    Report Number
    MW1005326
    Event Type
    Malfunction
    Date Received
    March 3, 1995
    Date of Event
    February 15, 1995
    Report Date
    February 17, 1995
    Manufacturer
    USCI DIV., C.R. BARD, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DO ANGIOPLASTY OF COMPLETE OCCLUSION OF RCA, .014 STANDARD WIRE BROKE OFF IN THE PROXIMAL SEGMENT OF RCA. WIRE FRAGMENT IMBEDDED IN ARTERY. NOT A DANGER TO PT. PT INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEERABLE GUIDE WIRE STANDARD WITH PTFE COATING DQX USCI DIV., C.R. BARD, INC. 11KE0274

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR