MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM; INTRODUCER, CATHETER

Model Number	TL-18S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a transjugular liver biopsy, the device malfunctioned.The doctor was unable to get the needle to penetrate the valve on the sheath in the kit.Another device was required to complete the procedure.

• Brand Name: TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 16395920
• Report Number: 16395920
• Device Sequence Number: 17564112
• Product Code: DYB
• UDI-Device Identifier: 00886333218523
• UDI-Public: (01)00886333218523(17)25102(10)2276674
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/13/2023
• Report Date (Section F): 02/13/2023

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-18S
• Device Catalogue Number: TL-18S
• Device Lot Number: 2276674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Race: White
• Date Report Sent to FDA: 02/13/2023