MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBSIDIO?; VASCULAR EMBOLIZATION DEVICE

Model Number	M0013972101010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product and event information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that aneurysm and gastrointestinal (gi) bleed occurred, requiring intervention and hospitalization.Obsidio conformable embolic was selected for use for a gastroduodenal artery (gda) embolization procedure.One week post procedure, aneurysm was observed.It was also noted that 30 days post procedure, the patient presented with a gastrointestinal (gi) bleed and imaging showed a proximal gda aneurysm with revascularization of obsidio.It was reported that the patient had a tumor growing next to the gda, and it was believed that this occurred due to the tumor growth pushing into the gdfa and obsidio.Embolic coils were used to occlude the aneurysm and bleed in the gda.The patient was hospitalized and fully recovered.

• Brand Name: OBSIDIO?
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 23348012
• Report Number: 2124215-2025-74775
• Device Sequence Number: 7807615
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)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: 2025
• 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): 10/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• 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: 09/22/2025
• Initial Report FDA Received Date: 10/21/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown