BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER

    MDR report key: 307948 · Received December 7, 2000

    Report

    Report Number
    2024168-2000-00302
    Event Type
    Injury
    Date Received
    December 7, 2000
    Date of Event
    November 9, 2000
    Report Date
    November 9, 2000
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PERFORM AN ATHERECTOMY/PTCA ON A CALCIFIED, OSTEAL LESION IN THE RIGHT CORONARY ARTERY (CONTRARY TO IFU). THE DEVICE WOULD NOT CROSS, AND IT WAS ADVANCED AND TWISTED AGAINST RESISTANCE (CONTRARY TO IFU). IT WAS NOTED THAT WHEN THE DEVICE WAS WITHDRAWN FROM THE PT, THE POLYURETHANE TIP HAD SEPARATED AND REMAINED ON THE GUIDE WIRE; IT WAS RETRIEVED FROM THE PT WITH A SNARE DEVICE. A VESSEL DISSECTION WAS OBSERVED CLOSE TO THE ILIAC BIFURCATION, WHICH WAS SUCCESSFULLY TREATED WITH A STENT. REPORTEDLY, THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER CORONARY ATHERECTOMY CATHETER MCX GUIDANT VASCULAR INTERVENTION NA 0092851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention AMPLATZ GOOSENECK SNARE.| 4.0/18 & 3.5/15 RANGER BALLOON CATHETER,| .018 GUIDE WIRE,