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	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the physician found a defect in the spring and was unable to collect the sample.The procedure was completed with a new product.No patient injury or harm.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The sample was unable to collect a sample in a mode.The device failure mode was updated to have insufficient sampling.The root cause was not determined.A search of the complaint database was performed and seven 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: 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: 24698749
• Report Number: 1721504-2026-00944
• Device Sequence Number: 16068224
• Product Code: KNW
• UDI-Device Identifier: 00884450443699
• UDI-Public: 00884450443699
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/26/2026

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: A1411/B
• Device Lot Number: I3129641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/26/2026
• 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