MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MICRO PLUG SET; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	KA90001
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports that when attempting to close the patent ductus arteriosus (pda) with a 5 millimeter device, it seemed oversized and was recaptured and replaced with a 4 millimeter device.Later follow-up imaging showed a gradient was in the aorta.The decision was made to surgically remove the device.The patient is doing fine.No additional details were provided.Per dr.(b)(6): late aortic protrusion requiring removal of the device surgically.Device was implanted by dr.(b)(6).Based on a brief conversation with dr.(b)(6) on 2/16/24, dr.(b)(6) was using the micro plug set to treat a patient with pda.He initially attempted to close the pda with a 5 mm (ka90002) device - it seemed oversized and was recaptured and replaced with a 4 mm (ka90001) device.At later follow-up imaging, a gradient was noted in the aorta.The decision was made to surgically remove the device.The patient is doing fine.
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.

• Brand Name: MICRO PLUG SET
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24901269
• Report Number: 3012276280-2026-00001
• Device Sequence Number: 8938400
• Product Code: KRD
• UDI-Device Identifier: 00867966000112
• UDI-Public: 00867966000112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: KA90001
• Device Lot Number: 202882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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