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

Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Embolism/Embolus (4438)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that a visualization issue occurred resulting in a non-target embolism.Obsidio was selected for use to treat a gastrointestinal (gi) bleed in the superior mesenteric artery (sma).The vessel size was.06mm.During the procedure, a total of 0.15ml of obsidio was injected through the.021 truselect microcatheter, using the aliquot method.The physician was unable to see the obsidio exit the catheter, resulting in a series of small vessels being embolized instead of the targeted single small vessel.The patient experienced some minor pain a few days post procedure, with possible minor necrosis.This condition resolved relatively quickly, and the patient fully recovered after a hospital stay.
Event or Problem Description
It was reported that a visualization issue occurred resulting in a non-target embolism.Obsidio was selected for use to treat a gastrointestinal (gi) bleed in the superior mesenteric artery (sma).The vessel size was.06mm.During the procedure, a total of 0.15ml of obsidio was injected through the.021 truselect microcatheter, using the aliquot method.The physician was unable to see the obsidio exit the catheter, resulting in a series of small vessels being embolized instead of the targeted single small vessel.The patient experienced some minor pain a few days post procedure, with possible minor necrosis.This condition resolved relatively quickly, and the patient fully recovered after a hospital stay.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.D4: unique identifier (udi) #: updated from (b)(4) to (b)(4).H6: evaluation method codes (2): added analysis of production records code.

• 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: 18487076
• Report Number: 2124215-2023-75719
• Device Sequence Number: 3533978
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/02/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/02/2024
• 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: Hospitalization
• Patient Sex: Female