MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM

Model Number	TL-19
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
The physician was performing a trans jugular biopsy of the liver.On insertion of the product it did not cut the sample as required and on examination the mid section of the device was damaged.The coating on the device was unraveled as well with a sharp protruding metal piece.As the patient had a very high inr with high risk of bleeding this device was replaced with another device of the same model which performed 100% and adequate samples were extracted.
Additional Manufacturer Narrative
Device evaluation: one opened device was returned for evaluation.Visual inspection found that the cannula was damaged at the distal end, and the complaint was confirmed.The device was could not be test fired due to the damage of the cannula.The device was disassembled and it was found that the cannula had become loose from the glue pocket.It is possible that the device was fired after the cannula was loose, which caused the stylet to come in contact with the cannula and damaging it.An internal investigation has been opened to document our investigation into the cause of this problem and the corrective actions that are being taken.There were no other complaints found related to (b)(4).A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.

• Brand Name: TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM
• Common Device Name: TLAB
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18411949
• Report Number: 0001417485-2023-00012
• Device Sequence Number: 8767752
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 00886333218516
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TL-19
• Device Lot Number: 2810314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown