MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1550
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient underwent a galaxy-assisted bronchoscopy procedure on (b)(6) 2024.Two days later, on (b)(6) 2025, the patient suffered a stroke and was hospitalized, receiving anticoagulation therapy as part of their treatment.No malfunctions of the galaxy device were reported during the procedure, and no products are expected to be returned for evaluation.A review of the galaxy system procedure log confirmed that no system errors occurred during the procedure that were relevant to the reported event.Furthermore, the physician does not attribute the use of the galaxy device as a contributing factor to the stroke.Since the stroke occured following the use of the galaxy product, this incident is being reported.
Event or Problem Description
Following a noah galaxy device-assisted bronchoscopy procedure on (b)(6) 2024, the patient experienced a stroke on (b)(6) 2025.As a result, the patient was hospitalized and treated with anticoagulation therapy.No malfunctions related to the noah galaxy device were reported during the procedure.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95131
• Manufacturer (Section G): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 21200488
• Report Number: 3021325287-2025-00001
• Device Sequence Number: 12175683
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)240702
• 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): 01/15/2025

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 Catalogue Number: CRB-1550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American