BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET

    MDR report key: 11132412 · Received January 7, 2021

    Report

    Report Number
    2134265-2020-18647
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 18, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, IT WAS FOUND THAT THE CATHETER WAS LEAKING BLOOD INTO THE CONSOLE BEFORE THE PROCEDURE. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26089 ANGIOJET CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1