BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERIS BALLOON DILATION CATHETER

    MDR report key: 18318575 · Received December 13, 2023

    Report

    Report Number
    3005803389-2023-00001
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    September 3, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BRYAN MEDICAL, INC.
    Product Code
    KTI
    UDI-DI
    B472KG10301
    PMA / PMN Number
    K150951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND IT WAS FOUND THAT THE DEVICE WAS CORRECTLY MANUFACTURED ACCORDING TO ALL REQUIREMENTS AND SPECIFICATIONS. THE DOCTOR DID NOT MAKE A REPORT TO BRYAN MEDICAL OF THE PRODUCT BEING FAULTY. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. END USER REPORTED THE EVENT TO THE FDA DIRECTLY; THEREFORE, BRYAN MEDICAL INC. HAS MADE THE DECISION TO REPORT THE EVENT AS WELL. THERE WAS NO PATIENT INJURY OR HARM, THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION."

    Description of Event or Problem · 0

    PROCEDURE - FLEXIBLE BRONCHSCOPY WITH BALLOON DILATION. 10MM AERIS BALLOON DILATION CATHETER: PER DR., THE BALLOON WAS INFLATED WHILE IN THE PATIENT AND THE BALLOON BROKE IN THE PATIENT. PER DR., NO PRODUCT/BALLOON RESIDUAL WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296944 AERIS BALLOON DILATION CATHETER BRONCHOSCOPE (FLEXIBLE OR RIGID) KTI BRYAN MEDICAL, INC. KG1030 1304305F B472KG10301

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male