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

Catalog Number	A149/B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
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 is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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 no similar complaints 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.The unit was returned with opened packaging and evidence of clinical use.Visual inspection showed no physical damage; needle and tip areas were intact.Simulated clinical use testing was conducted, the device was able to collect sample in (d) mode, however, sample collection in a mode failed to retrieve any sample.The complaint was confirmed.The root cause could not be established.A search of the complaint database was performed and eight similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• 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: 22794289
• Report Number: 1721504-2025-00243
• Device Sequence Number: 8286965
• Product Code: KNW
• UDI-Device Identifier: 10885403088384
• UDI-Public: 10885403088384
• 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): 12/12/2025

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: I3129634
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 12/11/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/09/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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