MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOD ULTRASOUND GUIDED BIOPSY NE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00502060
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an inod ultrasound guided biopsy needle was to be use in a inod navigational bronchoscopy procedure performed on (b)(6) 2024.During preparation, the package was found partially opened.They couldn't use the device and completed the procedure by opening a new one.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block d2b: pro code (product code) is eoq, itx.Block h6: device code a020503 captures the reportable event of packaging seal compromised.

• Brand Name: INOD ULTRASOUND GUIDED BIOPSY NE
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20910646
• Report Number: 3005099803-2024-06338
• Device Sequence Number: 18292662
• Product Code: EOQ
• UDI-Device Identifier: 00191506020729
• UDI-Public: 00191506020729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221340
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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 Expiration Date: 05/09/2026
• Device Model Number: M00502060
• Device Catalogue Number: M00502060
• Device Lot Number: 0034002622
• 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: 11/21/2024
• Initial Report FDA Received Date: 12/12/2024
• 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
• Patient Sex: Unknown