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

Model Number	M00558220
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: additional pro code: fcg.Block h6: imdrf device code a041001 captures the reported event of needle tip has punctured the sheath.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary was used in the lungs during an ultrasound-guided bronchial needle aspiration biopsy procedure performed on (b)(6) 2025.During procedure, the needle tip has punctured the sheath.Another same device was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary was used in the lungs during an ultrasound-guided bronchial needle aspiration biopsy procedure performed on (b)(6) 2025.During procedure, the needle tip has punctured the sheath.Another same device was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d2b: additional pro code: fcg block h6: imdrf device code a041001 captures the reported event of needle tip has punctured the sheath.Block h11: the returned expect pulmonary was analyzed, and a visual inspection found the working length was kinked at the distal section.A functional test found the needle was able to extend and it was observed that the needle punctured the sheath when actuated.The customer provided pictures where it was possible to observe the working length was kinked at distal section, and the needle punctured the sheath.The reported event of needle punctured sheath was confirmed.Based on all available information, a kink in the working length may be caused by operational factors, such as manipulating the device through difficult anatomy, the technique for the device manipulation, or by the interaction between the device and the scope (hitting against a hard surface).If the needle was extended while the working length is kinked, it could puncture the sheath.Based on all available information, the investigation conclusion code is "adverse event related to procedure".

• Brand Name: EXPECT 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22052082
• Report Number: 3005099803-2025-02199
• Device Sequence Number: 8908304
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409(17)271008(10)35019902
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151315
• 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): 07/18/2025

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: M00558220
• Device Catalogue Number: M00558220
• Device Lot Number: 0035019902
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 79 KG