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

Model Number	M00552350
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used in the right lower paratracheal node during a transbronchial needle aspiration (tbna) procedure performed on (b)(6) 2023.During the procedure, the needle tip broke and remained lodged in the right lower paratracheal node.The patient underwent a computed tomography (ct) scan, which confirmed the needle tip was lodged in the node and they were discharged the same day.The needle tip could not be retrieved without mediastinoscopy or video-assisted thoracoscopic (vat) surgery.The procedure was completed using an alternate device and the patient's outcome is currently unknown.
Additional Manufacturer Narrative
Block g4 (premarket/510k): k163248, k151895.Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment.
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used in the right lower paratracheal node during a transbronchial needle aspiration (tbna) procedure performed on (b)(6) 2023.During the procedure, the needle tip broke and remained lodged in the right lower paratracheal node.The patient underwent a computed tomography (ct) scan, which confirmed the needle tip was lodged in the node and they were discharged the same day.The needle tip could not be retrieved without mediastinoscopy or video-assisted thoracoscopic (vat) surgery.The procedure was completed using an alternate device and the patient's outcome is currently unknown.
Additional Manufacturer Narrative
Block g4 (premarket/510k): k163248, k151895.Block h6: imdrf device code a0501 captures the reportable event of distal tip detachment.Block h10: investigation results: the returned acquire pulmonary needle was analyzed and it was found that a portion of the distal tip of the needle was detached.Additionally, a photo of the device outside the patient was provided by the customer and it is possible to observe that the distal tip of the needle was detached.The reported event is confirmed.It is possible that the needle tip could have detached due to operational factor such as needle insertion technique or a tangential load applied at the time of puncture.Based on the analysis of the returned device and all the information available, the most probable root cause is adverse event related to procedure.

• 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: 17512031
• Report Number: 3005099803-2023-04193
• Device Sequence Number: 20819086
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/18/2023

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 Expiration Date: 03/13/2026
• Device Model Number: M00552350
• Device Catalogue Number: 5235
• Device Lot Number: 0031228474
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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