MAUDE Adverse Event Report: MERIT MEDICAL IRELAND EN SNARE®; DEVICE, PERCUTANEOUS RETRIEVAL

Catalog Number	EN1003008/B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that the snare broke during a retrieval procedure.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.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.

• Brand Name: EN SNARE®
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): MERIT MEDICAL IRELAND; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer (Section G): MERIT MEDICAL IRELAND; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23658629
• Report Number: 1721504-2025-00648
• Device Sequence Number: 10055106
• Product Code: MMX
• UDI-Device Identifier: 00884450452431
• UDI-Public: 00884450452431
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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 Expiration Date: 08/30/2026
• Device Catalogue Number: EN1003008/B
• Device Lot Number: K2813325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown