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	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: the remaining pro code (product code) is fcg; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block e1: initial reporter facility name: (b)(6).Block g4: the remaining premarket/510(k) are k151895 and k163248; reported here as premarket/510(k) exceeded the character limit for the designated field.Block h6: imdrf device code a041001 captures the reportable event of punctured sheath.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the airway during an ultrasound bronchoscopy procedure on (b)(6) 2025.During the procedure, puncture needle could not cross the track of the sheath and came out from the side of the sheath.The procedure was completed using another expect pulmonary needle.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.

• 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: 22209332
• Report Number: 3005099803-2025-02638
• Device Sequence Number: 8158640
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409(17)280114(10)35623374
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 0035623374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 01/14/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG