MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00552350
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ACQUIRE PULMONARY
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18181464
• Report Number: 3005099803-2023-06302
• Device Sequence Number: 7890289
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00552350
• Device Catalogue Number: 5235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown