BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO JET VENTILATION CATHETER

    MDR report key: 24402695 · Received February 20, 2026

    Report

    Report Number
    3041679947-2026-00001
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 17, 2026
    Manufacturer
    PIPELINE MEDICAL PRODUCTS, LLC
    Product Code
    BTR
    UDI-DI
    00860014685200
    PMA / PMN Number
    K243579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED AND A REVIEW OF THE DHR WAS PERFORMED. DEVICE MANUFACTURED ACCORDING TO ALL REQUIREMENTS AND SPECIFICATIONS. ALL RECORDS REVIEWED, NO ANOMALIES WERE NOTED IN MANUFACTURING PROCESS. INCLUDING PACKAGING, LABELING, STERILIZATION OR MATERIALS USED. RETURNED PRODUCT WAS INSPECTED AND TESTED, NO DEFECTS NOTED AND THE DEVICE PERFOMS AS SPECIFIED. CAUSE OF ISSUE INDETERMINATE AT TIME OF REPORT.

    Description of Event or Problem · 0

    PATIENT WAS UNDERGOING A SUSPENSION MICROSCOPIC LARYNGOSCOPY (SML) USING JET VENTILATION. DURING THE PROCEDURE THE PATIENTS O2 LEVEL DECREASED. THE JET VENTILATION TUBE WAS REMOVED AND A STANDARD ENDOTRACHEAL TUBE WAS INSERTED. O2 LEVELS STABILIZED AND THE PROCEDURE WAS COMPLETED. POST OPERATIVELY A CT SCAN WAS DONE WHICH SHOWED MILD BILATERAL PNEUMOTHORAX. PATIENT WENT BACK TO THE OR WHERE A DIAGNOSTIC BRONCHOSCOPY WAS PERFORMED TO ASSESS THE AIRWAY. THERE WAS NO EVIDENCE OF TRACHEAL DAMAGE OR TRACHEAL TEARS. NO BLEEDING WAS NOTED. PATIENT HAD BILATERAL CHEST TUBES PLACED TO TREAT THE PNEUMOTHORAX. PATIENT STAYED ADDITIONAL DAYS IN THE HOSPITAL UNTIL THE PNEUMOTHORAX RESOLVED AND CHEST TUBES WERE REMOVED. PATIENT DISCHARGED. CAUSE OF EVENT IS INDETERMINATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462952 AERO JET VENTILATION CATHETER JET VENTILATION TUBE BTR PIPELINE MEDICAL PRODUCTS, LLC AERO-SA1 1210514A 00860014685200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O