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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports while doing an in-service for the siege vascular plug and after prepping the plug, the physician inserted the plug into the catheter and stated 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.The anatomy was not torturous.No additional details were 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.The device was retuned for investigation.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.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): 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: 24905886
• Report Number: 3012276280-2026-00012
• Device Sequence Number: 13230036
• 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: 204656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• 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: 12/27/2024
• 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