MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY OLYMPUS 22GA - BOX 5; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00558221
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a041001 captures the reportable event of the material puncture/hole.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the upper lungs during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2025.During the procedure, the needle got stuck in the sheath and was not possible to push it through.After removing the scope from the patient, the health care professional tried to push the needle through.However, the needle tip shoot out through the side of the sheath.Another expect pulmonary was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the upper lungs during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2025.During the procedure, the needle got stuck in the sheath and was not possible to push it through.After removing the scope from the patient, the health care professional tried to push the needle through.However, the needle tip shoot out through the side of the sheath.Another expect pulmonary was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d2b: the remaining pro code (product codes) is k151895; reported here as pro codes (product codes) exceeded character limit for designated field.Block h2 correction: block d4 (model number and catalog number) corrected.Block h6: device code a041001 captures the reportable event of the needle punctured sheath.Block h11: investigation results the returned expect pulmonary needle was received for analysis.Visual examination revealed that the working length was kinked.A functional test was performed by actuating the device, and the needle was able to extend but was observed kinked as well.The sheath was observed under magnification and was found that the needle punctured the sheath.Additionally, a picture was provided by the customer which showed the needle punctured the sheath.The reported event was confirmed.Based on the available information, the working length kinked and the needle kinked could be caused if excessive force is used in order to complete the punctured in the procedure.Also, if the needle is extended while it is bent it can cause the sheath to be punctured.Therefore, a review and analysis of all available information indicated the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: EXPECT PULMONARY OLYMPUS 22GA - BOX 5
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21675573
• Report Number: 3005099803-2025-01050
• Device Sequence Number: 7600247
• Product Code: EOQ
• UDI-Device Identifier: 08714729861430
• UDI-Public: (01)08714729861430(17)271025(10)35145364
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K163248
• 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): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558221
• Device Catalogue Number: M00558221
• Device Lot Number: 0035145364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/23/2025
• Date Device Manufactured: 10/25/2024
• 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
• Patient Sex: Unknown