BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 17641490 · Received August 29, 2023

    Report

    Report Number
    17641490
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 4, 2023
    Manufacturer
    BALT USA LLC
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COIL TRACKED INTO ARTERY, UPON ATTEMPT TO RETRACT, THE COIL DETACHED FROM THE DELIVERY SYSTEM. ONE LOOP OF COIL NOW RESIDES IN THE ARTERY THE REST IN THE SAC OF THE ANEURYSM. ADDITIONAL STENT REQUIRED IN THE ARTERY TO TACK THE COIL TO THE WALL OF THE VESSEL TO MAINTAIN PATENCY OF THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173596 OPTIMA COIL SYSTEM DEVICE, NEUROVASCULAR EMBOLIZATION HCG BALT USA LLC F230500843

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Female Other