BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR

    MDR report key: 1871330 · Received September 30, 2010

    Report

    Report Number
    1871330
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    June 30, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING PERCUTANEOUS CORONARY INTERVENTION, PHYSICIAN WANTED TO USE ROTABLATOR ON PATIENT. WHEN READY TO TEST THE ROTABLATOR MACHINE, THE MACHINE FAILED. BOTH MACHINES WERE TRIED AND FAILED. AFTER MUCH TROUBLESHOOTING, THE MACHINE COULD NOT BE USED. BIOMED INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC RC 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR