BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS EXTRA S'PORT .014 300CM LONG

    MDR report key: 36544 · Received July 3, 1996

    Report

    Report Number
    36544
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Date of Event
    May 22, 1996
    Report Date
    May 27, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE UNRAVELED DURING STENT PLACEMENT IN CARDIAC CATHETERIZATION LAB. WIRE REPLACED WITH NEW AND STENT PLACEMENT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS EXTRA S'PORT .014 300CM LONG PTCA GUIDEWIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 22235MJ 6040451

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other