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

Catalog Number	SVP2.5-0.021
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while doing an in-service for the siege vascular plug and after prepping the plug, the physician inserted the plug into the catheter and started to push.The siege plug became stuck and after many unsuccessful attempts to advance the plug, the physician pulled it back out of the catheter, where it was discovered that the distal tip started to curl up.There was no reported patient harm.No additional information was provided.
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.During secondary review it was determined this event was reported under g8 number 3012276280-2026-00012 where the manufacturer number and name was inadvertently reported incorrectly.This report with g8 number is the correct report for the siege plug as it is manufactured in south jordan, utah.We will send a cancellation for the other report indicating this one is correct.The device was returned for investigation and photos were taken of the returned product.The distal end of the delivery was damaged (coiled up).This is caused by the loader not being fully seated on the catheter hub, but the wire is pushed causing it to coil and bunch up.Each of the recommended compatible microcatheters was evaluated for device transfer with the damaged device.The distal tip of the loader was held in contact with the microcatheter hub and in all cases the device transferred smoothly through the hub and into the proximal section of the microcatheter.The plug and wire were successfully transferred into other recommended catheters.Therefore, the complaint is not confirmed.This complaint will be used to trend for similar complaints.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.

• Brand Name: SIEGE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): 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: 25280144
• Report Number: 1721504-2026-00067
• Device Sequence Number: 18586105
• Product Code: KRD
• UDI-Device Identifier: 00884450815908
• UDI-Public: 00884450815908
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K240261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: SVP2.5-0.021
• Device Lot Number: 204656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown