MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BIOSENTRY®; ABSORBABLE LUNG BIOPSY PLUG

Catalog Number	H787768022019S1/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The 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.The suspect device was returned for evaluation.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were found.This complaint will be used to trend for similar complaints.The complaint was confirmed, however the root cause could not be determined.
Event or Problem Description
The customer reports the physician had finished taking all biopsy samples and they were ready to deploy the biosentry plug.They noticed the patient already had a pneumo so they were ready to deploy the plug and finish the case.They opened up one biosentry plug and noticed the pusher would not advance through the adaptor so it could not deploy.They opened up another biosentry plug of the same lot, but noticed this one was not able to advance all the way through the adaptor either.At this point they opened up an older lot they had on hand to complete the procedure.The patient also required a blood patch.No additional details provided.

• Brand Name: BIOSENTRY®
• Common Device Name: ABSORBABLE LUNG BIOPSY PLUG
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana bc, 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; 19970-b roberto de la madrid; tijuana bc, 22630 ; MX 22630
• Manufacturer Contact: mr. cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24717433
• Report Number: 1721504-2026-00153
• Device Sequence Number: 5763250
• Product Code: OMT
• UDI-Device Identifier: 00884450808122
• UDI-Public: 00884450808122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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 Date: 07/19/2025
• Device Catalogue Number: H787768022019S1/A
• Device Lot Number: I2859231
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown