MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ACHIEVE® BIOPSY NEEDLE; INSTRUMENT, BIOPSY

Catalog Number	A149/B
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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.
Event or Problem Description
The account alleges the clincian fired the device but could not tell if the device had closed.While pulling the needle from the patient, it was felt that it closed.The sample retrieved was deemed inadequate.A new device was used to continue the procedure.No additional patient consequence to report.
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 five similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.This complaint will be used to trend for similar complaints.Corrective actions are taken as warranted based on trend analysis per internal procedure.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The returned device was found open with a slightly bent needle (stylet), which contributed to difficulty in arming the mechanism and ultimately prevented successful sample collection.The root cause of the bent stylet is most likely attributed to wear and tears, rather than a manufacturing defect.The complaint was confirmed.The root cause could not be established.A search of the complaint database was performed and five 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.

• Brand Name: ACHIEVE® BIOPSY NEEDLE
• Common Device Name: INSTRUMENT, BIOPSY
• 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
• MDR Report Key: 22650582
• Report Number: 1721504-2025-00200
• Device Sequence Number: 8798348
• Product Code: KNW
• UDI-Device Identifier: 00884450443736
• UDI-Public: 00884450443736
• 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,Followup
• Report Date (Section B): 09/25/2025

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: A149/B
• Device Lot Number: I3129862
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 09/24/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2025
• 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