BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA-OS

    MDR report key: 24520031 · Received March 5, 2026

    Report

    Report Number
    MW5184764
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    February 18, 2026
    Report Date
    February 27, 2026
    Manufacturer
    FRONT LINE MEDICAL TECHNOLOGIES INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COBRA OCCLUSION BALLOON CATHETER USED IN FEMORAL ARTERY. DURING REMOVAL, BALLOON DEFLATED AND RESISTANCE WAS FELT. VALIDATED BALLOON WAS DEFLATED. BALLOON DETACHED FROM CATHETER REQUIRING ADDITIONAL PROCEDURES TO RETRIEVE THE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585097 COBRA-OS CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN FRONT LINE MEDICAL TECHNOLOGIES INC. 673120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L