MAUDE Adverse Event Report: KA MEDICAL 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	07/23/2025
Type of Reportable Event	Malfunction
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 device was retuned for investigation.Components returned included the plug, loader and delivery wire.The most likely cause of the issue is the loader was not fully seated in the microcatheter hub per the instructions for use (ifu) and during device transfer the plug deployed in the hub rather than transferring into the proximal portion of the microcatheter.Continued advancement with the plug deployed in the hub caused damage to the distal tip of the delivery wire.Each of the recommended compatible microcatheters were 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.This complaint is not confirmed because the defect was caused from use error and was successfully deployed into the recommended catheters.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.
Event or Problem Description
The customer reports they tried to deploy a siege vascular plug and it did not deploy.No additional details were provided.

• Brand Name: SIEGE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): KA MEDICAL; 1265 grey fox road; suite 550; arden hills MN 55112
• Manufacturer Contact: 1265 grey fox road; suite 550; arden hills, MN 55112 ; 6512622810
• MDR Report Key: 24901271
• Report Number: 3012276280-2026-00014
• Device Sequence Number: 15687986
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 204708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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
• Patient Sex: Unknown