MAUDE Adverse Event Report: GT MEDICAL TECHNOLOGIES GAMMATILE; RADIONUCLIDE BRACHYTHERAPY SEEDS

Model Number GT-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebral Edema (4403)

Event Type  Injury  

Event Description

Patient presented with edema after tumor resection and gammatile implant.

Manufacturer Narrative

Patient presented with cerebral edema after tumor resection and gammatile implant.

• Brand Name: GAMMATILE
• Type of Device: RADIONUCLIDE BRACHYTHERAPY SEEDS
• Manufacturer (Section D): GT MEDICAL TECHNOLOGIES; 350 hills street; suite 108; richland WA 99354
• Manufacturer (Section G): GT MEDICAL TECHNOLOGIES; 350 hills street; suite 108; tempe WA 99354
• Manufacturer Contact: jessica newhard ; 1809 s holbrook lane; suite 107; tempe, AZ 85281 ; 4802768609
• MDR Report Key: 16025313
• MDR Text Key: 305917982
• Report Number: 3014663932-2022-00032
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GT-001
• Device Catalogue Number: GT-06
• Device Lot Number: 00000915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention