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

Catalog Number	EN2006015/CNB
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation; however, one image of the suspect device was provided.The investigation involved review of the image.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 product history 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 complaints.
Event or Problem Description
It was reported that the tip of the snare broke inside a patient's body, during the process of grasping foreign objects, which prolonged the procedure.No patient injury or medical intervention was reported.The device was successfully removed from the patient.No additional information is available.

• 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 (Section G): MERIT MEDICAL IRELAND, LTD.; 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: 25284889
• Report Number: 9616662-2026-00015
• Device Sequence Number: 13181133
• Product Code: MMX
• UDI-Device Identifier: 00884450452455
• UDI-Public: 00884450452455
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: EN2006015/CNB
• Device Lot Number: K3421976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown