BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 15601297 · Received October 13, 2022

    Report

    Report Number
    3005099803-2022-05779
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K: PREMARKET / 510(K) #: K163248, K151895 . (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE NEEDLE WAS INSERTED INTO THE BRONCHIAL TREE AND THE SHEATH WAS BLOCKED AND RIGID. IT HAD BEEN SLIGHTLY FORCED BUT IT LEAKED, AND IT WAS NO LONGER POSSIBLE TO ADJUST. AFTER THE PROCEDURE, IT WAS NOTED THE DISTAL PART OF THE BRONCHOSCOPE WAS DAMAGED. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY DUE TO THE INABILITY TO ADJUST THE SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601361 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 0029635503 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown