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

Model Number	M0013972101010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that material separation and non-target embolization occurred with no sequelae.Obsidio was selected for mid proximal splenic embolization of a pseudoaneurysm, in combination with embold, interlock and non-boston scientific coils.Two syringes of obsidio were used.The patient did not have normal anatomy, and a previously replaced hepatic off the sma which was believed to be fine.Non-target embolization was experienced through a feeder to the dorsal pancreatic vessel that had enlarged and some of the obsidio did go to the liver.There were no patient complications as a result of this event and the patient made a full recovery.A 2.4 non-boston scientific microcatheter was also used for this case.

• 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: 24308657
• Report Number: 2124215-2026-07524
• Device Sequence Number: 9678674
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 02/10/2026

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
• 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: 01/14/2026
• Initial Report FDA Received Date: 02/10/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.4 PROGREAT
• Patient Sex: Unknown