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 not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.Should the device return for evaluation the complaint investigation will be re-opened.
Event or Problem Description
The account alleges during a left breast biopsy procedure, the biopsy needle retrieved inadequate samples.A new needle was used and the procedure was successfully completed.No additional patient consequence to report.

• 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: 22650581
• Report Number: 1721504-2025-00218
• Device Sequence Number: 21032227
• 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
• Report Date (Section B): 07/29/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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