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

Model Number	TL-19
Medical Device Problem Codes	Failure to Obtain Sample (2533); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Exsanguination (1841); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/23/2023
Type of Reportable Event	Death
Event or Problem Description
The reported device would not acquire any tissue samples during a transjugular liver biopsy.When the device was removed from the patient, the provider reported that the distal portion of the biopsy needle was bent/curved and looked unusual although nothing abnormal was observed under fluoroscopy during the procedure.Another device was used without difficulty to obtain the biopsy.Following the biopsy procedure, the patient had intraperitoneal hemorrhage requiring blood transfusions and hepatic artery embolization.Ct imaging demonstrated a large volume hemoperitoneum, and physical exam findings were concerning for abdominal compartment syndrome.The patient was in the process of being taken to the operating room for abdominal decompression when he arrested and subsequently expired.

• Brand Name: ARGON TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM
• Common Device Name: TLAB
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 18103768
• Report Number: 18103768
• Device Sequence Number: 6004185
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 00886333218516
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2023
• Report Date (Section F): 10/24/2023

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 Expiration Date: 05/17/2026
• Device Model Number: TL-19
• Device Catalogue Number: TL-19
• Device Lot Number: 2528728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• 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: Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 10/24/2023