BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENTRY TRACT SEALANT SYSTEM

    MDR report key: 18366492 · Received December 20, 2023

    Report

    Report Number
    3011642792-2023-00078
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 22, 2023
    Report Date
    November 28, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    QMT
    UDI-DI
    05051684016516
    PMA / PMN Number
    DEN090007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES A PORTION OF THE PLUNGER STYLET BROKE OFF WITHIN THE PATIENT. THERE WAS RESISTANCE WHILE DEPLOYING THE PLUG AND USUAL FORCE WAS USED TO REMOVE IT. THE PATIENT WAS SENT FOR A CONSULTATION WITH A THORACIC SURGEON BUT SINCE THE PATIENT WAS EXPERIENCING NO SYMPTOMS DUE TO THE RETAINED FOREIGN BODY, THE DECISION WAS MADE BY THE CLINICAL STAFF TO LEAVE IT IN PLACE. NO ATTEMPT WILL BE MADE TO REMOVE THE IFB FROM THIS PATIENT. THE PATIENT IS DOING WELL AND IS CURRENTLY UNBOTHERED BY THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016356 BIOSENTRY TRACT SEALANT SYSTEM ABSORBABLE LUNG BIOPSY PLUG QMT MERIT MEDICAL SYSTEMS MEXICO 05051684016516

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown