BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHEROCATH-GTO ATHERECOMY DEVICE

    MDR report key: 128638 · Received October 24, 1997

    Report

    Report Number
    2024168-1997-00150
    Event Type
    Malfunction
    Date Received
    October 24, 1997
    Date of Event
    September 24, 1997
    Report Date
    September 24, 1997
    Manufacturer
    GUIDANT ACS/DVI
    Product Code
    MCX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A DCA PROCEDURE, WHILE AN ASPIRATION PREP WAS BEING PERFORMED ON THE BALLOON, THE NOSE CONE SEPARATED FROM THE DEVICE. ANOTHER GTO DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS NOT USED IN A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO ATHERECOMY DEVICE CORONARY ATHERECTOMY DEVICE MCX GUIDANT ACS/DVI NA 7072451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other