BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE PT GUIDEWIRE

    MDR report key: 7178827 · Received January 10, 2018

    Report

    Report Number
    7178827
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    May 16, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CHOICE PT GUIDEWIRE WAS USED IN CONJUNCTION WITH AN OUTBACK RE-ENTRY DEVICE. DURING GUIDEWIRE MANIPULATION THROUGH THE NEEDLE OF DEVICE, THE TIP OF THE WIRE WAS SHED OFF INTO THE SUBINTIMAL SPACE OF THE LT POPLITEAL ARTERY. SINCE THE WIRE TIP WAS NOT LEFT WITHIN THE TRUE LUMEN OF THE VESSEL, NO HARM WAS DONE TO THE PATIENT AND NO FURTHER ACTION WAS TAKEN BY DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21925 CHOICE PT GUIDEWIRE GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR