BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 11488138 · Received March 15, 2021

    Report

    Report Number
    2134265-2021-03213
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 7, 2021
    Report Date
    March 15, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE COULD NOT SHOW ROTATION SPEED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CONSOLE COULD NOT SHOW THE READING DATA UNDER HIGH SPEED MODE AND ABLATION COULD NOT BE PERFORMED. THE PHYSICIAN USED THE CUTTING BALLOON INSTEAD TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383736 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR