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

Model Number	TL-19
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2021
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 it has been received and reviewed.
Event or Problem Description
System malfunctioning, due to the incorrect exposure of the tru-cut needle notch.See enclosed video.The procedure has been completed, by discarding the device and using another one of the same code/batch #.No patient injury.
Event or Problem Description
System malfunctioning, due to the incorrect exposure of the tru-cut needle notch.See enclosed video.The procedure has been completed, by discarding the device and using another one of the same code/batch #.No patient injury.
Additional Manufacturer Narrative
No sample was returned for evaluation.A video was provided that showed the device not functioning correctly, and the complaint was confirmed.Since the device was not returned for evaluation, a root cause could not be determined.If more information become available, a follow-up will be submitted.
Additional Manufacturer Narrative
One opened device was returned for evaluation.Visual inspection found that the retaining/cocking button was broken.Functional inspection found that the cannula was broke loose from the glue pocket, which would cause the stylet to not retract into the cannula.The complaint was confirmed.The most likely cause of this issue was due to hitting fibrous or calcified material during activation of the device.As this issue was most likely cause due to an event in the user environment, no corrective action was taken.Argon will continue to monitor for recurrence.
Event or Problem Description
System malfunctioning, due to the incorrect exposure of the tru-cut needle notch.See enclosed video.The procedure has been completed, by discarding the device and using another one of the same code/batch #.No patient injury.

• 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: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12643746
• Report Number: 0001625425-2021-01099
• Device Sequence Number: 16510886
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 886333218516
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2021

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 Expiration Date: 11/28/2023
• Device Model Number: TL-19
• Device Lot Number: 1567860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 09/28/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/18/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown