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

Catalog Number GT-06

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/23/2020

Event Type  Injury  

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 Description

7 weeks post- implantation the patient had to undergo removal of the gammatiles due to an infection.

• Brand Name: GAMMATILE
• Type of Device: RADIONUCLIDE BRACHYTHERAPY SEEDS
• Manufacturer (Section D): GT MEDICAL TECHNOLOGIES; 1809 s holbrook lane; suite 107; tempe AZ 85281 6051
• Manufacturer (Section G): ISORAY MEDICAL, INC; 350 hills street; suite 106; richland WA 99354
• Manufacturer Contact: jessica newhard ; 1809 s holbrook lane; suite 109; tempe, AZ 85281-6051 ; 4802768609
• MDR Report Key: 10797260
• MDR Text Key: 215017827
• Report Number: 3014663932-2020-00001
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 60860000064509
• UDI-Public: (01)60860000064509(11)200327(17)200403(10)DO2013037
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GT-06
• Device Lot Number: D02013-037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention