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

Catalog Number	ONE401/JP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The used device was returned without its original packaging.Upon evaluation,used guidewire was found stuck in a 2.3f catheter.Snare head detachment was observed.It was suspected that likely cause of snare head damage could be excessive force applied during manipulation or retrieval.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 complaints.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
Customer alleged during an endoscopic third ventriculostomy (evt) procedure, the loop of the product detached during an attempt to grasp the guidewire and temporarily remained in the patient's body.A second product from the same lot was opened, allowing retrieval of the detached loop, and the procedure was completed using the opened guidewire.The patient injury was a temporary in-body retention.

• Brand Name: ONE 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: 24699169
• Report Number: 1721504-2026-00939
• Device Sequence Number: 21472086
• Product Code: MMX
• UDI-Device Identifier: 00884450122921
• UDI-Public: 00884450122921
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ONE401/JP
• Device Lot Number: K3368615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown