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

Model Number TL-19N

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The investigation is in progress.A follow-up report will be provided once the investigation has been completed.

Event Description

A tlab kit was used during a tj liver biopsy case and the radiopaque marker band from the sheath came off and migrated to the patient's lungs.

Event Description

Follow up.

• Brand Name: TRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM
• Type of Device: TLAB
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10737653
• MDR Text Key: 215576311
• Report Number: 1625425-2020-00698
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00886333218554
• UDI-Public: 00886333218554
• Combination Product (y/n): N
• PMA/PMN Number: K022634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: TL-19N
• Device Catalogue Number: TL-19N
• Device Lot Number: 1451430
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention