BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

    MDR report key: 19907764 · Received August 5, 2024

    Report

    Report Number
    3005172759-2024-00084
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PNZ
    UDI-DI
    10705031230880
    PMA / PMN Number
    DEN150056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. SINCE THIS ADVERSE EVENT REQUIRES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. THERE ARE NO REPORTED MALFUNCTIONS WITH ANY ACCLARENT DEVICES USED DURING THE CASE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ACCLARENT, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ACCLARENT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (ENT (EAR, NOSE & THROAT) PROCEDURE WITH ACCLARENT DEVICES (ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM) EXPERIENCED A SYNCOPE EPISODE AND WENT INTO ASYSTOLE DURING THE PROCEDURE. IT WAS REPORTED THAT THE EVENT WAS CONFIRMED BY A PHYSICIAN-ANESTHESIOLOGIST WITH A HEART RATE MONITOR. IT WAS ALSO REPORTED THAT THE PATIENT WAS REVIVED WITH MEDICATION AND OXYGEN. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS ALSO NOTED THAT THE EVENT OCCURRED WHEN THE DILATION SYSTEM¿S BALLOON WAS DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028055 ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ ACCLARENT, INC. 10705031230880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R