MAUDE Adverse Event Report: MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V. ACHIEVE®; INSTRUMENT, BIOPSY,

Catalog Number	A1825/B
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device is expected to be returned for evaluation.A follow up report will be submitted when investigation and product history review are complete.
Event or Problem Description
It was reported that during micro-guided biopsy, no tissue core was found in the sampling slot after the needle was withdrawn from the patient.A back-up device was used to complete the procedure.No patient injury, medical or surgical intervention was reported.

• Brand Name: ACHIEVE®
• Common Device Name: INSTRUMENT, BIOPSY,
• Manufacturer (Section D): MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, 22630 ; MX 22630
• Manufacturer (Section G): MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V.; 19970 interior b, edificio 2; tijuana 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25246218
• Report Number: 3011642792-2026-00006
• Device Sequence Number: 9596846
• Product Code: KNW
• UDI-Device Identifier: 00884450443941
• UDI-Public: 884450443941
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/10/2026

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: A1825/B
• Device Lot Number: 13347499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown