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

Model Number GT-001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  malfunction  

Event Description

During the implantation of order: (b)(4) at (b)(6) hospital, one of eight tiles demonstrated partial delamination of the top (i.E.Smooth) layer of collagen.The delamination exposed the vicryl sutures.

Manufacturer Narrative

No adverse event reported.

• 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: 16534897
• MDR Text Key: 311583445
• Report Number: 3014663932-2023-00006
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 60860000064509
• UDI-Public: (01)60860000064509(11)230213(17)230220(10)00001218
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GT-001
• Device Catalogue Number: GT-08
• Device Lot Number: 00001218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• 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