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 Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
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) 2024.During the procedure, the needle punctured through the side of the sheath and injured the physician.When the needle was inserted, the physician got injured/punctured.The physician went to an infectious disease hospital to receive a hepatitis b antibody injection.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 e1: initial reporter facility name: (b)(6).Block g4 (premarket/ 510k#): k151315, k151895, k163248.Block h6: imdrf impact code f2303 captures the reportable event of hepatitis b antibody injection that was given to the physician due to the needle stick.Imdrf device code a041001 captures the reportable event of needle punctured sheath.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20686084
• Report Number: 3005099803-2024-05709
• Device Sequence Number: 8557042
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: 08714729861409
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558220
• Device Catalogue Number: M00558220
• Device Lot Number: 0033997594
• 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: 10/23/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 62 KG