• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARGON MEDICAL DEVICES TRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM TLAB Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM
Type of DeviceTLAB
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key11227588
MDR Text Key229643831
Report Number1625425-2021-00835
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K022634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
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
Date FDA Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTL-19
Device Catalogue NumberTL-19
Device Lot Number1451428
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/25/2021 Patient Sequence Number: 1
-
-