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
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used during an ultrasound bronchoscopy procedure on (b)(6) 2025.During the procedure, the needle tip had pierced the needle sheath.The procedure was completed using another expect pulmonary needle.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block d2b: additional pro code: fcg block g4: additional premarket / 510(k) #'s: k151895, k163248.Block h6: imdrf device code a041001 captures the reportable event of needle punctured sheath.
Additional Manufacturer Narrative
Block h11: report number 3005099803-2025-02754 was opened for an expect pulmonary needle event where it was reported that "after completing the first needle puncture sampling with an airway ultrasound puncture needle, it was found that the needle tip had pierced the needle sheath".On 19jun2025, additional information was received that report number 3005099803-2025-02754 was a duplicate with 3005099803-2025-02199.It was also mentioned that the correct event date was 24apr2025 and the patient age was 58 years old.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used during an ultrasound bronchoscopy procedure on (b)(6) 2025.During the procedure, the needle tip had pierced the needle sheath.The procedure was completed using another expect pulmonary needle.There were no reported patient complications as a result of this event.

• 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: 22284608
• Report Number: 3005099803-2025-02754
• Device Sequence Number: 18361704
• 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: Other Health Care Professional
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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