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 Necrosis (1971)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

The patient was originally diagnosed in (b)(6) 2022 with a right temporal gbm.The tumor was resected and the patient received adjuvant radiation therapy of 60gy in 30 fractions between (b)(6), 2022 and (b)(6), 2022 along with chemotherapy.On (b)(6), 2022 a recurrent tumor was resected in the previous radiated field and the patient was treated with gammatile therapy.Radiation necrosis was identified and starting on (b)(6), 2022 the patient required medical treatment to preclude permanent impairment.Due to the previous radiation treatment and this being a re-radiation, it is not knwon whether gammatile casued or contributed to the radiation necrosis that was experienced.As of (b)(6) 2023, the patient was doing well.

Event Description

Patient experienced radiation necrosis approximately 2 months post implant which required medical intervention.

• 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; richland WA 99354
• Manufacturer Contact: jessica newhard ; 1809 s holbrook lane; suite 107; tempe, AZ 85281 ; 4802768609
• MDR Report Key: 16624905
• MDR Text Key: 312102260
• Report Number: 3014663932-2023-00010
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 50860000064502
• UDI-Public: (01)50860000064502(11)221007(17)221014(10)00001035
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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-05
• Device Lot Number: 00001035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2023
• 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
• Treatment: MAINTENANCE CHEMOTHERAPY; OPTUNE TTF
• Patient Outcome(s): Required Intervention