BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 18181464 · Received November 21, 2023

    Report

    Report Number
    3005099803-2023-06302
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 17, 2023
    Report Date
    January 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G4 (PREMARKET/ 510(K) #): K163248, K151895. BLOCK H2: CORRECTION: BLOCK B5 WAS UPDATED TO INCLUDE THE PATIENT BEING TREATED FOR A MALIGNANT TUMOR. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF DETACHMENT OF DEVICE OR DEVICE COMPONENT IMDRF IMPACT CODE E2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE USED TO RETRIEVE DETACHED PIECE. BLOCK H10: INVESTIGATION RESULTS: THE RETURNED ACQUIRE PULMONARY NEEDLE WAS ANALYZED, AND A VISUAL INSPECTION OBSERVED THAT THE WORKING LENGTH WAS KINKED IN THE DISTAL SECTION. A MICROSCOPE INSPECTION NOTED THAT THE NEEDLE WAS RETURNED WITHOUT THE DISTAL SECTION. NO OTHER VISUAL DAMAGES WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS AND PATIENT ANATOMY (TUMOR) COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED DURING THE PROCEDURE. ALSO, AN EXISTING CONDITION OR DISEASE IS DEMONSTRABLY RESPONSIBLE FOR THE ADVERSE EVENT, AND THE USE OF THE DEVICE HAS NEITHER CAUSED NOR OTHERWISE INFLUENCED THIS CONDITION OR DISEASE-RELATED EVENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PATIENT CONDITION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, A SHIP HISTORY REVIEW WAS PERFORMED TO IDENTIFY THE MOST PROBABLE LOTS, AND A DEVICE HISTORY REVIEW (DHR) ON THE MOST PROBABLE LOTS DID NOT IDENTIFY ANY ANOMALIES OR DEVIATIONS WITHIN MANUFACTURING/SERVICE PROCESSES THAT COULD HAVE CONTRIBUTED TO THE EVENT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G4 (PREMARKET/ 510(K) #): K163248, K151895. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF DETACHMENT OF DEVICE OR DEVICE COMPONENT. IMDRF IMPACT CODE E2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE USED TO RETRIEVE DETACHED PIECE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DUE TO A TUMOR IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE DETACHED INSIDE THE PATIENT. ATTEMPTS TO RETRIEVE THE DETACHED NEEDLE WERE UNSUCCESSFUL AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. FOLLOWING THE PROCEDURE, A CHEST X-RAY WAS PERFORMED, WHICH REVEALED A METAL MATERIAL APPROXIMATELY 10-MM LONG. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND NO INTERVENTION FOR THE DETACHED NEEDLE IS PLANNED AS THE PATIENT IS ILL, HAS A MALIGNANT TUMOR AND IS IN PALLIATIVE CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE DETACHED INSIDE THE PATIENT. ATTEMPTS TO RETRIEVE THE DETACHED NEEDLE WERE UNSUCCESSFUL AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. FOLLOWING THE PROCEDURE, A CHEST X-RAY WAS PERFORMED, WHICH REVEALED A METAL MATERIAL APPROXIMATELY 10-MM LONG. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND NO INTERVENTION FOR THE DETACHED NEEDLE IS PLANNED AS THE PATIENT IS ILL AND IN PALLIATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993384 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention