BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 11337207 · Received February 17, 2021

    Report

    Report Number
    11337207
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 15, 2021
    Report Date
    February 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893363
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC ADAPTER AND WIRES CAME APART EASILY WHEN REMOVING THEM FROM THE SYSTEM. THIS HAPPENED AFTER THE CASE, AFTER THE SYSTEM WAS REMOVED FROM THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235451 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION H749393001500 26197584 08714729893363

    Patients

    Seq Age Sex Outcome Treatment
    1