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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM; TLAB
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ARGON MEDICAL DEVICES TRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM; TLAB Back to Search Results
Model Number TL-19N
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/09/2020
Type of Reportable Event Malfunction
Additional 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 or Problem 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 or Problem Description
Follow up.
 
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Brand Name
TRANSJUGULAR LIVER ACCESS BIOPSY SYSTEM
Common Device Name
TLAB
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key10737653
Report Number1625425-2020-00698
Device Sequence Number3644565
Product Code DYB
UDI-Device Identifier00886333218554
UDI-Public00886333218554
Combination Product (Y/N)N
Initial Reporter StateIL
PMA/510(K) Number
K022634
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 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
Operator of Device Health Professional
Device Expiration Date08/11/2023
Device Model NumberTL-19N
Device Catalogue NumberTL-19N
Device Lot Number1451430
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/13/2020
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date10/26/2020
Supplement Report FDA Received Date12/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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