BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER

    MDR report key: 312209 · Received January 12, 2001

    Report

    Report Number
    2024168-2001-00017
    Event Type
    Injury
    Date Received
    January 12, 2001
    Date of Event
    December 14, 2000
    Report Date
    December 15, 2000
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE IN 12/2000, A GTO WAS USED TO TREAT IN-STENT RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY. THE GTO WOULD NOT COMPLETELY CROSS THE STENT, SO IT WAS USED TO DEBULK THE PORTION OF THE LESION WHICH WAS ACCESSIBLE (CONTRARY TO IFU, USE OF A DEVICE WITH A 4.0MM WORKING DIAMETER IN A 3.0MM STENT). AFTER DEBULKING, A STENT STRUT WAS BELIEVED TO BE STUCK IN THE HOUSING WINDOW, AND THE DEVICE COULD NOT BE REMOVED. CABG WAS PERFORMED, AND THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424 ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER CORONARY ATHERECTOMY CATHETER MCX GUIDANT VASCULAR INTERVENTION NA 0092252

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention EFFECTIVENESS OF THE PACEMAKER.| ALIANTE 2.0/20 DILATATION CATHETER, GRAND SLAM| STENT. PACEMAKER IMPLANTED 12/2000, ADD'L DRUG| GUIDE WIRE, DVI INFLATION DEVICE, ZUMA 9FJCR 4.0| SHEATH, ATLANTIS IVUS, AVE S670 STENT, AVE GFX| GUIDING CATHETER, SHEEMAN RHV, TERUMO 9F 25CM| THERAPY WAS ADMINISTERED TO ENHANCE THE