BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERIS BALLOON DILATION CATHETER 7MMX30MM

    MDR report key: 25102477 · Received May 6, 2026

    Report

    Report Number
    MW5187801
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BRYAN MEDICAL, INC
    Product Code
    KTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN AERIS DILATION CATHETER SIZE 7X30 WITH A TOTAL INFLATION RATE OF 17 WAS BEING USED AND THE CATHETER BALLOON BUSTED. PHYSICIAN EXAMINED PATIENT AND NOTED NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226917 AERIS BALLOON DILATION CATHETER 7MMX30MM BRONCHOSCOPE ACCESSORY KTI BRYAN MEDICAL, INC KG0730 15055160

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other