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

Model Number TL-19

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

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 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 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 279247831
• Report Number: 0001625425-2021-01099
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 886333218516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 09/28/2021; 09/28/2021
• Supplement Dates FDA Received: 11/18/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other