BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS CORO WIRE

    MDR report key: 35299 · Received July 1, 1996

    Report

    Report Number
    35299
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    January 15, 1996
    Report Date
    January 24, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CATHETERIZATION, WIRE BECAME LOCKED IN 90% OCCLUDED ARTERY. TIP OF WIRE UNRAVELLED AND BROKE OFF IN ANTERIOR LEFT DESCENDING ARTERY. APPROX 16 CM LEFT IN PT. PT UNDERWENT EMERGENCY OPEN HEART SURGERY. PT DISCHARGED TO HOME 1/20/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS CORO WIRE CORO WIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 22318M

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R