BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 7109420 · Received December 6, 2017

    Report

    Report Number
    7109420
    Event Type
    Death
    Date Received
    December 6, 2017
    Date of Event
    November 20, 2017
    Report Date
    November 30, 2017
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH STEMI, CATH PROCEDURE SHOWING 99 PERCENT MED LESION OF RIGHT CORONARY ARTERY. ATTEMPTED MULTIPLE PASSAGES TO LESION BALLOON INFLATION DONE, STENT PLACED AND MIGRATED. IDENTIFIED PERFORATION RCA; PATIENT EXPIRED. RIGHT CORONARY ARTERY PERFORATION WHILE PHYSICIAN USING DEVICE; PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869186 BOSTON SCIENTIFIC CHOICE FLOPPY (LS) GUIDEWIRE DQX BOSTON SCIENTIFIC 19340812

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death