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

Catalog Number	A149/B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The needle tip was examined under magnification where no damage was observed and alignment was normal.The device was armed and fired without any difficulties.Upon testing, two out of three fires in a mode failed to retrieve samples.Firing in d mode successfully collected sample in both attempts.The device has been confirmed to have insufficient sampling.The root cause was not determined.A search of the complaint database was performed, and two similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
Event or Problem Description
During a breast biopsy with ultrasound guidance, the healthcare provider was unable to draw back to retrieve sample from needle.Tried again once biopsy was complete, and pt had left the room and was able to force the sample from the needle.No patient harm.

• Brand Name: ACHIEVE®
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 24575387
• Report Number: 1721504-2026-00909
• Device Sequence Number: 9158313
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Device Catalogue Number: A149/B
• Device Lot Number: I3129634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown