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

Model Number	M0013972001010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that migration occurred.Obsidio was selected for use in a splenic embolization procedure.Obsidio was used off label for the vessel size and traveled outside the desired area occluded.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.D6a: implant date: no date provided, used the first date in the month of the aware date.Detailed product information was not provided to boston scientific.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.Good faith effort attempts were made to retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that migration occurred.Obsidio was selected for use in a splenic embolization procedure.Obsidio was used off label for the vessel size and traveled outside the desired area occluded.There were no patient complications as a result of this event.It was further reported that the desired amount of obsidio that traveled outside the parameters was intended and purposeful and the patient did not experience any harm.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.D6a: implant date: no date provided, used the first date in the month of the aware date.Detailed product information was not provided to boston scientific.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.Good faith effort attempts were made to retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 23722659
• Report Number: 2124215-2025-88948
• Device Sequence Number: 10209544
• Product Code: KRD
• UDI-Device Identifier: 00191506039332
• UDI-Public: (01)00191506039332
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Followup
• Report Date (Section B): 12/22/2025

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: M0013972001010
• Device Catalogue Number: M0013972001010
• 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: 11/08/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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
• Patient Sex: Unknown