MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS ACHIEVE®; BIOPSY NEEDLE

Catalog Number	A1411/B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
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 review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that when attempting to take biopsies the biopsy device failed to collect a sample.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause is likely due to improper pin and spring assembly performed by the operators during the manufacturing process.Issue-(b)(4) has been initiated for further investigation.A search of the complaint database was performed and seven similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Corrective actions are taken as warranted.Trend data will be used to monitor complaints and the performance of production processes and quickly address any deviations from established standards.

• Brand Name: ACHIEVE®
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22910000
• Report Number: 1721504-2025-00304
• Device Sequence Number: 8863139
• Product Code: KNW
• UDI-Device Identifier: 10885403088346
• UDI-Public: 10885403088346
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141552
• 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,Followup
• Report Date (Section B): 09/09/2025

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: A1411/B
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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