BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER

    MDR report key: 84106 · Received April 4, 1997

    Report

    Report Number
    2024168-1997-00051
    Event Type
    Malfunction
    Date Received
    April 4, 1997
    Date of Event
    March 5, 1997
    Report Date
    April 4, 1997
    Manufacturer
    ACS/DVI
    Product Code
    MCX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE CLEANING THE NOSECONE PORTION OF THE DIRECTIONAL CORONARY ARTHRECTOMY DEVICE IT WAS NOTED THAT THE NOSE CONE HAD SEPARATED. THE DEVICE HAD BEEN USED IN A CALCIFIED CIRCUMFLEX LESION. REPORTEDLY, THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT AS THIS SEPARATION OCCURRED OUTSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER ATHRECTOMY DEVICES MCX ACS/DVI NA 6102151

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other