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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-18N
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 11/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complaint is part of a health risk evaluation which is currently in progress for the tlab non-conformance.The corrective actions will be determined once the evaluation is completed.
 
Event or Problem Description
Transjugular liver biopsy where a 3-4mm piece of the tlab sheath broke off and was sent to the inferior pulmonary artery.
 
Additional Manufacturer Narrative
H3 other text : placeholder.
 
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 Key10854667
Report Number1625425-2020-00710
Device Sequence Number11570283
Product Code DYB
UDI-Device Identifier00886333218530
UDI-Public00886333218530
Combination Product (Y/N)N
Initial Reporter StateCA
PMA/510(K) Number
K022634
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 11/16/2020
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 Date07/02/2023
Device Model NumberTL-18N
Device Catalogue NumberTL-18N
Device Lot Number1419198
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date11/17/2020
Supplement Report FDA Received Date12/10/2020
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 Other;
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