MAUDE Adverse Event Report: OBSIDIO, INC. OBSIDIO; VASCULAR EMBOLIZATION DEVICE

Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that material separation occurred.Obsidio was selected for use in the splenic artery.During the procedure, obsidio was delivered using the standard technique.Obsidio began to fill the nest of the 8x40 non-boston scientific coil and proceeded to fill the vessel proximal to the coil.The next morning, a computerized tomography (ct) scan identified fragments of obsidio that traveled beyond the coil and distal into the spleen.No additional actions were required.There were no patient complications and the patient was in good condition post procedure.

• Brand Name: OBSIDIO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OBSIDIO, INC.; 2 scimed pl; maple grove 55331
• Manufacturer (Section G): OBSIDIO, INC.; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19393454
• Report Number: 2124215-2024-31832
• Device Sequence Number: 6946413
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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
• 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: 05/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown