MAUDE Adverse Event Report: NOAH MEDICAL INC. GALAXY SYSTEM

Model Number	GALB-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure analysis investigation of the scope was performed.Physical inspection of the scope revealed that there were no hardware defects.The scope was performing as expected.Video logs confirmed the intermittent em signal loss, but the user continued with the procedure using live fluoroscopy.The cause of the injury is a cardio embolism according to the physician.The complaint is reported due to the following findings: after a galaxy assisted biopsy procedure, the patient developed a stroke with intervention of tissue plasminogen activator and admission to the icu for approximately 21 days.The patient was discharged to the rehabilitation unit with left sided paralysis.
Event or Problem Description
It was reported that after a galaxy assisted biopsy of a lesion located at the anterior, right upper lobe, the patient developed a stroke.As a result of the complication, the patient was taken to the post-anesthesia care unit and still intubated.The stroke was confirmed via ct scan and mri imaging, confirmed by a neurologist.The patient was started on tissue plasminogen activator and was admitted to the icu.The patient was discharged to the rehabilitation unit with left sided paralysis.Information to gather the exact discharge date was unsuccessful.The physician does not attribute the injury to the galaxy system.Brief occurrence of em signal loss was reported during navigation, while the user continued with live fluoroscopy without interruption, and no injury was observed during the time of em signal loss.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• 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: 20700871
• Report Number: 3021325287-2024-00012
• Device Sequence Number: 6583833
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202408060117250200
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 02/01/2025
• Device Model Number: GALB-001
• Device Lot Number: 2024080601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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; Disability; Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White