BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC V-18 CONTROL WIRE

    MDR report key: 2073505 · Received April 19, 2011

    Report

    Report Number
    2073505
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 9, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY MALE UNDERGOING A SELECTIVE CATHETERIZATION AND ANGIOGRAPHY OF THE RIGHT ANTERIOR TIBIAL ARTERY. A 0.018 QUICK CROSS CATHETER AND GUIDEWIRE WERE USED. DURING THE CATHETERIZATION, THE TIP OF THE GUIDEWIRE BROKE OFF IN THE ARTERY BEYOND THE END OF THE CATHETER. THE WIRE TIP WAS RETRIEVED AND REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC V-18 CONTROL WIRE GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR