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

Catalog Number	GT-06
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two cases have been reported to the manufacturer regarding adverse events after the implantation of gammatile.These incidents occurred on different dates with different patients.The lots of gammatiles were separate lots used by the same medical institution.The collagen carrier in the two batches was from different lots.The sterilization was done on two separate dates.The cs-131 radiative radioactive source seeds were from two different lots.It is currently unknown if the adverse events are related to the use of gammatile.The medical physicist did report that there were about 2 times as many clinicians in the room to observe the surgery.Gt medical has attempted follow-up with the user via email and phone but have been unable to obtain additional information.Additional follow-up will be attempted and the mdr will be updated as additional information becomes available.
Event or Problem Description
3 weeks post-implantation the patient had to undergo removal of the gammatiles due to an infection.

• Brand Name: GAMMATILE
• Common Device Name: RADIONUCLIDE BRACHYTHERAPY SEEDS
• Manufacturer (Section D): GT MEDICAL TECHNOLOGIES; 1809 s holbrook lane; suiye 107; tempe AZ 85281 6051
• MDR Report Key: 10797264
• Report Number: 3014663932-2020-00002
• Device Sequence Number: 3931543
• Product Code: KXK
• UDI-Device Identifier: 60860000064509
• UDI-Public: (01)60860000064509(11)200901(17)200904(10)DO2036009
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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 Catalogue Number: GT-06
• Device Lot Number: DO2036-009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention