BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIST 079

    MDR report key: 19749744 · Received July 16, 2024

    Report

    Report Number
    19749744
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 17, 2024
    Report Date
    June 18, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQY
    UDI-DI
    00763000413767
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RADIAL ACCESS GUIDE CATHETER WOULD NOT ADVANCE IN BRACHIAL ARTERY. UPON REMOVAL, THE CATH STARTED TO UNWIND AND TIP BROKE OFF. X-RAY IMAGES CONFIRMED TIP IN VESSEL. UPON COMPLETION OF NEURO INTERVENTION, THE PATIENT WAS TAKEN TO THE OR (OPERATING ROOM) FOR SUCCESSFUL RETRIEVAL OF CATHETER BY VASCULAR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504949 RIST 079 CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. 107F-079-95 23945-1004042027 00763000413767

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention| O