MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY OLYMPUS 25GA - BOX 5; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00558251
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g4: premarket / 510(k) #: k163248 & k151895.Block h6: imdrf device code a0501 is being used to capture the reportable issue of distal tip broke.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the airway during procedure on (b)(6) 2024.During the procedure, the distal tip broke after biopsying a lymph node.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 OLYMPUS 25GA - 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20925535
• Report Number: 3005099803-2024-06274
• Device Sequence Number: 8320352
• Product Code: EOQ
• UDI-Device Identifier: 08714729861447
• UDI-Public: 08714729861447
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: M00558251
• Device Catalogue Number: 5825-5
• Device Lot Number: 0034956000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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