BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY OLYMPUS 22GA - BOX 5

    MDR report key: 18016151 · Received October 26, 2023

    Report

    Report Number
    3005099803-2023-05724
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 5, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895. IMDRF DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN DEVICE. INVESTIGATION RESULTS: THE EXPECT PULMONARY NEEDLE WAS RETURNED, AND A VISUAL INSPECTION OBSERVED THAT THE WORKING LENGTH WAS KINKED AT 2 CM OF THE PROXIMAL END OF THE HANDLE. A MICROSCOPE INSPECTION NOTED THAT THE NEEDLE WAS KINKED. A FUNCTIONAL INSPECTION WAS PERFORMED, AND THE STYLET WAS ABLE TO ADVANCE WITH NO ISSUE AND NO SIGNS OF INTERNAL OCCLUSION OR FOREIGN MATERIAL WERE FOUND DURING FLUSHING. ADDITIONALLY, A MEDIA INSPECTION WAS PERFORMED AS THE CUSTOMER PROVIDED SOME PICTURES WHICH SHOWED SOME KIND OF FOREIGN MATERIAL PRESENT ON THE PHYSICIAN'S GLOVE. THE REPORTED EVENTS WERE NOT CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENTS IS NO PROBLEM DETECTED AS THERE WERE NO SIGNS OF FOREIGN MATERIAL OR OCCLUSION, AND THE STYLET WAS ABLE TO ADVANCE WITHOUT ISSUE. HOWEVER, THE WORKING LENGTH AND NEEDLE WERE FOUND KINKED DURING ANALYSIS, THEREFORE THE MOST PROBABLE ROOT CAUSE FOR THOSE ISSUES IS ADVERSE EVENT RELATED TO PROCEDURE, AS THESE COULD HAVE BEEN CAUSED BY THE MANIPULATION OF THE DEVICE DURING ITS USE.

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895. BLOCK H6: IMDRF DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN THE SHEATH. PRESSURE WAS APPLIED AND THE NEEDLE EXTENDED WITH SOME STEEL COMPONENTS. ALSO, THE STYLET WAS HARD TO REINSERT INTO THE NEEDLE DUE TO SOME FOREIGN COMPONENTS IN THE LUMEN OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN THE SHEATH. PRESSURE WAS APPLIED AND THE NEEDLE EXTENDED WITH SOME STEEL COMPONENTS. ALSO, THE STYLET WAS HARD TO REINSERT INTO THE NEEDLE DUE TO SOME FOREIGN COMPONENTS IN THE LUMEN OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048050 EXPECT PULMONARY OLYMPUS 22GA - BOX 5 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558221 0031416900 08714729861430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown