MAUDE Adverse Event Report: KA Medical Plug.SIEGE¿; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	SVP4-0.021
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports during an embolization with the siege vascular plug, they deployed the plug and it was in situ for a few minutes.Then it migrated and lodged elsewhere in the body but did not clot the blood flow.No harm occurred to the patient and device was safely retrieved.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.

• Brand Name: Plug.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 (Section G): KA Medical; 1265 grey fox road suite 550; arden hills MN 55112
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50052737
• Report Number: 3012276280-2026-00006
• Device Sequence Number: 18507232
• Product Code: KRD
• UDI-Device Identifier: 00884450815915
• UDI-Public: 00884450815915
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SVP4-0.021
• Device Lot Number: 204722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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