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

Model Number	TL-19
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The investigation is in progress and a follow-up report will be provided once completed.
Event or Problem Description
Tip (distal 5mm) of the sheath seemed to tear away and almost dislodge during the procedure.Sheath stayed intact.
Event or Problem Description
Follow up.

• Brand Name: TRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM
• Common Device Name: TLAB
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10840513
• Report Number: 1625425-2020-00707
• Device Sequence Number: 3315684
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 00886333218516
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: K022634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 08/05/2023
• Device Model Number: TL-19
• Device Catalogue Number: TL-19
• Device Lot Number: 1451428
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1