MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. 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	09/06/2025
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 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 not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A search of the complaint database was performed and one similar complaint for this lot number were found.The device history record was reviewed, and no exception documents were found.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Visual inspection showed no physical damage, but evaluation revealed a stylet notch and failure to load for a second cycle.Although this failed during evaluation the failure mode was updated to failure to arm which is not a reportable failure mode.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and one similar complaint for this lot number was found.

• Brand Name: ACHIEVE®
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. CA 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c., UT 22630 ; MX 22630 ; 8012084225
• MDR Report Key: 23085435
• Report Number: 1721504-2025-00343
• Device Sequence Number: 18781464
• Product Code: KNW
• UDI-Device Identifier: 10885403088384
• UDI-Public: 10885403088384
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

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
• Device Lot Number: I3006854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 12/19/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/21/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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