BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 14781004 · Received June 22, 2022

    Report

    Report Number
    3005099803-2022-03281
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: K163248 & K151895. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL EMDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE TRACHEA DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AFTER OUR EXPECT NEEDLE GOT CONNECTED AND ATTEMPTING TO ASPIRE THE CYST, THE DEVICE PUNCTURED THE EBUS SCOPE. THE PHYSICIAN COMPLAINED THAT BECAUSE OF THE STIFFNESS OF THE EXPECT NEEDLE, IT WAS DIFFICULT TO TAKE THE SHEATH OUT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. 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
    291039 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0028616501 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown