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

Model Number	LOBO-3
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
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: jennifer wagner ; 8 argonaut; suite 100; aliso viejo, CA 92656 ; +1(949)446-9710
• MDR Report Key: 50742876
• Report Number: 3016444913-2026-00019
• Device Sequence Number: 8862036
• Product Code: KRD
• UDI-Device Identifier: 00850008222016
• UDI-Public: (01)00850008222016(10)26A0005(17)280212
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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 Model Number: LOBO-3
• Device Lot Number: 26A0005
• 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: 06/11/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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 Sex: Unknown