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	10/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the obsidio broke off and embolized.The target location was in the gastroduodenal artery (gda).The vessel size was 2.0 - 2.7 mm.Obsidio was selected for use.After obsidio was administered, the microcatheter was left in place for a few minutes prior to removing it.A piece of obsidio broke off and traveled to approximately 1cm away from the ostium.The target location was backfilled with an embold fibered coil, and the obsidio remained stable.There were no patient complications.

• Brand Name: OBSIDIO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OBSIDIO, INC.; 2 scimed pl; maple grove 55331
• Manufacturer (Section G): OBSIDIO; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18176969
• Report Number: 2124215-2023-65015
• Device Sequence Number: 7611294
• Product Code: KRD
• UDI-Device Identifier: 00191506039332
• UDI-Public: 00191506039332
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/20/2023

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?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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