MAUDE Adverse Event Report: Galvanize Therapeutics, Inc. Aliya; Aliya Needle

Model Number	GTI-00023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury

• Brand Name: Aliya
• Common Device Name: Aliya Needle
• Manufacturer (Section D): Galvanize Therapeutics, Inc.; 3200 bridge pkwy; redwood city CA 94065
• Manufacturer (Section G): Galvanize Therapeutics, inc.; 3200 bridge pkwy; redwood city CA 94065
• Manufacturer Contact: grace turovskiy ; 3200 bridge pkwy; redwood city, CA 94065 ; +1(650)268-4252
• MDR Report Key: 50826768
• Report Number: 3017185164-2026-00004
• Device Sequence Number: 10210779
• Product Code: OAB
• UDI-Device Identifier: 00850031859005
• UDI-Public: 00850031859005
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Model Number: GTI-00023
• Device Catalogue Number: GTI-00023
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown