MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC BIOSENTRY TRACT SEALANT SYSTEM; ABSORBABLE LUNG BIOPSY PLUG

Catalog Number	H787768022019S1
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biosentry plunger stylette will not pass through coaxial adapter to push out bio-seal plug.No patient harm reported.
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event to meet fda criteria for reporting.This report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included in this report.A dhr review was completed and an investigation of the returned complaint sample associated with complaint that the biosentry plunger stylet does not pass through the coaxial adapter.Root cause for this event was determined to be the distal end of the adaptor having a molding non-conformance where the tip is "necked down" resulting in the narrowing of the lumen id.A supplier corrective action report (scar) response was received with corrective actions implemented and verification of effectiveness (voe) completed in june/july 2023.The lot number in question was manufactured prior to the corrective actions implemented per scar.

• Brand Name: BIOSENTRY TRACT SEALANT SYSTEM
• Common Device Name: ABSORBABLE LUNG BIOPSY PLUG
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24730630
• Report Number: 1721504-2026-00133
• Device Sequence Number: 9215020
• Product Code: OMT
• UDI-Device Identifier: 00884450397725
• UDI-Public: 00884450397725
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN090007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H787768022019S1
• Device Lot Number: 5796168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown