BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA

    MDR report key: 23818406 · Received December 16, 2025

    Report

    Report Number
    3015967359-2025-01723
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 8, 2025
    Report Date
    February 4, 2026
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PNZ
    UDI-DI
    00857326005017
    PMA / PMN Number
    K163509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION IN B5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BILATERAL BALLOON DILATION OF THE EUSTACHIAN TUBES USING THE XPRESS BALLOON, THE PATIENT HAD TRIGEMINOCARDIAC REFLEX. AT INFLATION OF THE BALLOON ON EACH SIDE, THE PATIENT WENT INTO ASYSTOLE FOR 5 SECONDS BEFORE RETURNING TO BRADYCARDIA AND THEN RETURNING TO NORMAL POST BALLOON DILATION. THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH NO DELAYS, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION IS CURRENTLY BEING REQUESTED.

    Description of Event or Problem · 0

    THE SURGEON PROVIDED ADDITIONAL INFORMATION THAT NO ANATOMICAL ABNORMALITIES NOTED IN THE PATIENT CT SCAN PRIOR TO PROCEDURE. NO MEDICATIONS WERE PROVIDED. THE PATIENT IS NOTED TO BE DOING WELL IN POST PROCEDURE CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136379 XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA BALLOON DILATION CATHETER SYSTEMS PNZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 25112053 00857326005017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other