MAUDE Adverse Event Report: NOAH MEDICAL INC. GALAXY SYSTEM; GALAXY SYSTEM - BRONCHOSCOPE

Catalog Number	GALB-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2024, the patient was undergoing a biopsy procedure for a 21mm lesion in the left lower lobe when a pneumothorax was reported after the procedure was completed.A chest tube was placed then the patient was admitted and discharged in 24 hours in good condition.No further complications were reported.Although the product was not returned for investigation, the investigation of the product (lot# 2024061801) identified the root cause of the scope catheter stability as highly related to anatomy, such as airway size and tortuosity.For this case, the galaxy scope performed as intended and functioned as expected.
Event or Problem Description
On (b)(6) 2024, a pneumothorax was reported while the patient was undergoing a galaxy-assisted biopsy procedure for a 21mm lll lesion.The procedure was completed, and the pneumothorax occurred after the case.A chest tube was placed, the patient was then admitted and discharged after 24 hours in good condition.The injury was attributed to the instability of the catheter being used while using the noah scope.No further complications were reported.The product was not returned for investigation.The case was reviewed, and it was found that scope stability is highly related to anatomy, such as airway size and tortuosity.For this case, the galaxy scope did perform as intended and functioned as expected with no identified user errors.Although investigation findings concluded that the injury was not caused by the galaxy system, the involvement of the galaxy system in this case led to the decision to report.The initial submission was made (b)(6) 2024, additional attempt made 28oct2024.Support from emdr helpdesk received a resubmission requested.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM - BRONCHOSCOPE
• Manufacturer (Section D): NOAH MEDICAL INC.; 2075 zanker road; san jose CA 95131
• Manufacturer (Section G): NOAH MEDICAL INC.; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 20730618
• Report Number: 3021325287-2024-00010
• Device Sequence Number: 12344091
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202406180117241200
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: GALB-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American