MAUDE Adverse Event Report: GALVANIZE THERAPEUTICS ALIYA SYSTEM; LOW ENERGY DIRECT CURRENT THERMAL ABLATION SYSTEM

Patient Problem Nodule (4551)

Event Date 03/23/2023

Event Type  Injury  

Event Description

This report is in regards to questionable business practices with regard to the galvanize/aliya system.They are marketing this product as effective for treatment of pulmonary nodules.We tried it in 5 patients and it did not work at all.This is exceedingly dangerous as it is pulmonary ablation of lung nodules is a high risk procedure.We are publishing our experience now.However, this may not be enough to get the word out.I am getting word that they are aggressively selling this product to the ir community.I think this company is too focused on profits and not the outcomes of cancer patients.

• Brand Name: ALIYA SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT THERMAL ABLATION SYSTEM
• Manufacturer (Section D): GALVANIZE THERAPEUTICS
• MDR Report Key: 19003897
• MDR Text Key: 339064063
• Report Number: MW5153364
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

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?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White