MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENSNARE CATHETER

Catalog Number	EN2007030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
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
The account alleges that the flower portion of the ensnare detached from wire portion.Flower portion was left in the patient while the wire was removed.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was found to have detached during use.The root cause is unknown.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: ENSNARE CATHETER
• Common Device Name: SNARE CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22440621
• Report Number: 1721504-2025-00149
• Device Sequence Number: 3164116
• Product Code: MMX
• UDI-Device Identifier: 00884450452479
• UDI-Public: 00884450452479
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: EN2007030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown