BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERIS® BALLOON DILATION CATHETER

    MDR report key: 6510571 · Received April 21, 2017

    Report

    Report Number
    6510571
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 20, 2017
    Manufacturer
    BRYAN MEDICAL, INC
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING BRONCHOSCOPY AND BALLOON DILATION ON A PATIENT FOR SUBGLOTTIC STENOSIS, THE BALLOON DILATION CATHETER FAILED AND THE BALLOON LEAKED TOWARDS THE END OF USE. THE PATIENT WAS NOT HARMED. THE OP NOTE INDICATED THE BALLOON SPONTANEOUSLY RUPTURED AS THEY WERE CONCLUDING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292898 AERIS® BALLOON DILATION CATHETER BALLOON DILATION CATHETER EOQ BRYAN MEDICAL, INC Z2457638E

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR