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

Catalog Number	EN2006020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation; however, images of the suspect device were provided.The investigation involved review of the images.The complaint could not be confirmed.The root cause could not be determined.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.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar omplaints.
Event or Problem Description
It was reported that the tip of the trapper broke, during use on a patient.A new device was used to complete the procedure.No patient injury or medical intervention was reported.

• Brand Name: EN SNARE®
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): MERIT MEDICAL IRELAND, LTD; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer Contact: parkmore business park west; galway, H91 W-274
• MDR Report Key: 25176983
• Report Number: 9616662-2026-00016
• Device Sequence Number: 10138784
• Product Code: MMX
• UDI-Device Identifier: 00884450452462
• UDI-Public: 00884450452462
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092343
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: EN2006020
• Device Lot Number: K3398047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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