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

Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that non target embolization occurred.Obsidio was selected for use in an ovarian embolization procedure.The size of the left gonadal vein was approximately 6-7mm in diameter.One 6x20 embold coil and two 8x20 embold coils were implanted.The catheter containing the obsidio material was placed approximately 1 cm proximal to the embold coils and 2.5cc of obsidio was successfully implanted.It was noted that 2.0cc of obsidio was delivered using a non-aliquot technique and.5cc of obsidio was delivered using the aliquot technique.Upon review after case follow-up, non target embolization was observed at the proximal bifurcation, 2-3cm below the left renal vein.The patient status was stable 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; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18735699
• Report Number: 2124215-2024-09559
• Device Sequence Number: 5804737
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/19/2024

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: 01/23/2024
• Initial Report FDA Received Date: 02/19/2024
• 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: Other
• Patient Sex: Female