MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO EVOLUTION®; BIOPSY NEEDLE KIT

Catalog Number	VC1815
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
Customer alleged when inserting the biopsy needle into the coaxial needle, there was resistance and a grinding sound during insertion, so the coaxial needle was replaced with a different product.The procedure was completed without issue.There were no patient complications.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was found to function as expected.The root cause of the reported defect 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 EVOLUTION®
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23854522
• Report Number: 1721504-2025-00749
• Device Sequence Number: 10144049
• Product Code: KNW
• UDI-Device Identifier: 00884450398104
• UDI-Public: 00884450398104
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: VC1815
• Device Lot Number: H3055266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown