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

Model Number TL-19

Device Problems Break (1069); Entrapment of Device (1212); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Based on the images provided of the incident, the complaint can be confirmed.Argon has recalled tlab products for the 7f introducer sheath distal tip separating during procedures.Lot number 1451428 used in this incident was included in the recall that went into effect december 2020.It is unknown at this time why the complainant facility still had the product in its possession and used after the recall notifications were sent to customers.The manufacturing defect was identified before argon started receiving the complaints that prompted the recall.(b)(4) was performed and it adequately addressed the root causes and corrective/preventative actions taken.All affected lots were manufactured before the tip bonding process was updated.Corrective actions included modifying the tipping mandrels to shorten the narrowed tip to 0.300¿, adding band markings at 0.100¿ and 0.200¿ onto the mandrel to simplify the locating of the mandrel within the introducer sheath tube and aid in the alignment of the tube and mandrel within the tipping die by the operator.It also included adding a 100% bend test as well as 100% visual inspection for wrinkling to the inspection process.

Event Description

Radio-opaque band on the tip of the sheath broke off in the patient and traveled to a pulmonary artery in the patient.It's in a periphery artery and was left in the patient.Patient is fine and has no issues on test.

Event Description

Follow up.

Manufacturer Narrative

H3 other text: placeholder.

• 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: 11227588
• MDR Text Key: 229643831
• Report Number: 1625425-2021-00835
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00886333218516
• UDI-Public: 00886333218516
• 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: 01/22/2021

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: 08/05/2023
• Device Model Number: TL-19
• Device Catalogue Number: TL-19
• Device Lot Number: 1451428
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other