MAUDE Adverse Event Report: Okami Medical Inc. LOBO Vascular Occlusion System; Vascular embolization device

Model Number	LOBO-7
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction

• Brand Name: LOBO Vascular Occlusion System
• Common Device Name: Vascular embolization device
• Manufacturer (Section D): Okami Medical Inc.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): Okami Medical Inc.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer Contact: cora sim ; 8 argonaut; suite 100; aliso viejo, CA 92656 ; +1(949)446-9710
• MDR Report Key: 50742873
• Report Number: 3016444913-2026-00016
• Device Sequence Number: 8862034
• Product Code: KRD
• UDI-Device Identifier: 00850008222030
• UDI-Public: (01)00850008222030(10)25A0003(17)260411
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K220383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Expiration Date: 04/11/2026
• Device Model Number: LOBO-7
• Device Lot Number: 25A0003
• 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: 05/12/2025
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Male