BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 11349618 · Received February 19, 2021

    Report

    Report Number
    2134265-2021-02019
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    February 5, 2021
    Report Date
    February 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893363
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 1.50MM ROTAPRO AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. DURING INSERTION, THE BURR BECAME STUCK ON THE WIRE INSIDE THE BODY. THE DEVICES WOULD NOT RELEASE. THE BURR AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249272 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3243 0025926699 08714729893363

    Patients

    Seq Age Sex Outcome Treatment
    1