MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO ELITE¿; SOFT-TISSUE BIOPSY PROCEDURE KIT

Catalog Number	TEVC2010
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemoptysis (1887); Pneumothorax (2012)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during biopsy procedure, the provider was met with resistance wen removing the needle.The needle came out bent.The patient experienced hemoptysis and a small pneumothorax.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: TEMNO ELITE¿
• Common Device Name: SOFT-TISSUE BIOPSY PROCEDURE KIT
• 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: 24675883
• Report Number: 1721504-2026-00936
• Device Sequence Number: 10360395
• Product Code: KNW
• UDI-Device Identifier: 00884450397756
• UDI-Public: 00884450397756
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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
• Device Catalogue Number: TEVC2010
• Device Lot Number: H3210816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown