BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 11233430 · Received January 26, 2021

    Report

    Report Number
    3005099803-2021-00205
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 6, 2021
    Report Date
    March 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G5: PREMARKET / 510(K) # : K163248 & K151895 BLOCK H6: IMDRF MEDICAL DEVICE CODE A27 IS BEING USED TO CAPTURE THE REPORTABLE ISSUE OF ABORTED/CANCELLED PROCEDURE. BLOCK H10: INVESTIGATION RESULTS THE RETURNED EXPECT PULMONARY NEEDLE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE WORKING LENGTH WAS KINKED AT THE PROXIMAL AND DISTAL SECTION OF THE DEVICE. THE NEEDLE WAS ALSO KINKED. A FUNCTIONAL EVALUATION NOTED THAT THE NEEDLE WAS ABLE TO EXTEND AND RETRACT WITHOUT ANY ISSUES WHEN THE HANDLE WAS ACTUATED. NO OTHER ISSUES WERE NOTED. BASED ON ALL AVAILABLE INFORMATION AND THE CONDITION OF THE RETURNED DEVICE, IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING THE PROCEDURE CAN LEAD TO KINKING THE DEVICE MOST LIKELY WHEN THEY TRIED TO INSERT THE UNIT INTO THE SCOPE. IN ADDITION, IF THE NEEDLE HITS ANY HARD SURFACE OR IF THERE WAS ANY HARD TISSUE IT CAN RESULT IN NEEDLE BENT/KINKED. THE INVESTIGATION CONCLUDED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO OBTAIN THE SPECIMEN AND IT WAS SEEN ON THE ULTRASOUND SCREEN THAT THE NEEDLE WAS BENT. THE DEVICE WAS REMOVED FROM THE SCOPE AND IT WAS NOTICED THAT THE DISTAL TIP WAS BENT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    PREMARKET / 510(K) #: K163248 & K151895. (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO OBTAIN THE SPECIMEN AND IT WAS SEEN ON THE ULTRASOUND SCREEN THAT THE NEEDLE WAS BENT. THE DEVICE WAS REMOVED FROM THE SCOPE AND IT WAS NOTICED THAT THE DISTAL TIP WAS BENT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130699 EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00558250 0026503392 08714729861416

    Patients

    Seq Age Sex Outcome Treatment
    1