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

Catalog Number	A1411/B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined and insufficient sample collection was confirmed.Root cause has not yet been determined.A review of the complaint database was performed and five similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were identified.
Event or Problem Description
During a breast biopsy using the achieve biopsy needle, the release firing mode was very weak resulting in no sample captures.The customer indicted that they believed the spring could have been defective.A different needle from another lot was then used and was reported to work well.No reported injury.

• 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: 23487920
• Report Number: 1721504-2025-00596
• Device Sequence Number: 10488479
• Product Code: KNW
• UDI-Device Identifier: 10885403088346
• UDI-Public: 10885403088346
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 11/06/2025

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
• Device Catalogue Number: A1411/B
• Device Lot Number: I3129641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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