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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block g4: premarket / 510(k) #: k163248, k151895.Block h6: imdrf device code a0501 captures the reportable event of needle detached.
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used in the bronchial wall during a lung biopsy procedure performed on (b)(6)2023.During the procedure, the needle tip broke and remained stuck in the bronchial wall during the third puncture.The needle tip was removed using forceps and the patient had mild bleeding.The bleeding was treated by administering a 500mg transamine tablet to the patient to control the bleeding.The procedure was completed using another acquire pulmonary needle.It was reported that a computed tomography (ct) scan of the thorax was suggested to ensure no foreign body remained, however it is unknown at this time if one was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g4: premarket / 510(k) #: k163248, k151895.Block h6: imdrf device code a0501 captures the reportable event of needle detached.Block h10: investigation results one acquire pulmonary needle was received for analysis.Visual analysis of the returned device found that the working length was kinked near the handle and the stylet returned partially loading.The needle was found broken in the distal part.It was identified during a microscope inspection that the distal tip of the needle was bent.A functional inspection was performed by actuating the handle, and the needle came out without difficulty.No other device problems were noted.The reported event of "distal tip detached" is confirmed since the needle was broken at the distal end.It was determined the working length was kinked near the handle and identified that the distal tip of the needle was bent under a microscope.It is most likely the customer may have had to apply excessive force to extend the needle due to anatomical factors or the technique employed, resulting in the observed device problems.Based on the analysis of the returned device and the information available, the code selected as the most probable root 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.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 in the bronchial wall during a lung biopsy procedure performed on (b)(6) 2023.During the procedure, the needle tip broke and remained stuck in the bronchial wall during the third puncture.The needle tip was removed using forceps and the patient had mild bleeding.The bleeding was treated by administering a 500mg transamine tablet to the patient to control the bleeding.The procedure was completed using another acquire pulmonary needle.It was reported that a computed tomography (ct) scan of the thorax was suggested to ensure no foreign body remained, however it is unknown at this time if one was completed.There were no patient complications reported as a result of this event.

• 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: 16886818
• Report Number: 3005099803-2023-02315
• Device Sequence Number: 6326746
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 07/14/2023

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: 08/03/2024
• Device Model Number: M00552350
• Device Catalogue Number: 5235
• Device Lot Number: 0027778523
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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