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

Model Number	TL-19
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Death
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
According to the reporter: "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 absorbed 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 transfusion 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 or for abdominal decompression where he arrested and subsequently expired.".
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.After three notifications sent to customer, sample was not returned to argon for investigation.No additional information was received either.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.It is unclear if the bleeding was due to any device malfunction or a procedural complication.At this time, no malfunction was identified without the sample.If the sample is returned at a future date, a follow-up report will be submitted.
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 absorbed 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 transfusion 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 or for abdominal decompression where he arrested and subsequently expired.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information provided in d.4.

• 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: 18148768
• Report Number: 0001625425-2023-01240
• Device Sequence Number: 7609219
• Product Code: KNW
• UDI-Device Identifier: 00886333218516
• UDI-Public: (01)00886333218516(17)260517(10)2528728
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2026
• Device Model Number: TL-19
• Device Lot Number: 2528728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 09/01/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/11/2024; 09/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Sex: Male