BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCED CARDIOVASCULAR SYSTEMS

    MDR report key: 15100 · Received April 12, 1994

    Report

    Report Number
    15100
    Event Type
    Other
    Date Received
    April 12, 1994
    Date of Event
    July 13, 1993
    Report Date
    July 23, 1993
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A PTCA, AND USING A .014 H1-TORQUE FLOPPY GUIDE WIRE (ADVANCED CARDIOVASCULAR SYSTEMS, LOT #3052652), THE COIL TIP BROKE OFF IN THE CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED CARDIOVASCULAR SYSTEMS FLOPPY GUIDE WIRE ADVANCED CARDIOVASCULAR SYSTEMS 3052652

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other