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

Model Number	M0013972101010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Embolism/Embolus (4438)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 28-year-old, at the time of enrollment.
Event or Problem Description
It was reported that migration occurred.The subject underwent the index procedure on (b)(6) 2025.The target lesion was located in the renal artery with a vessel diameter of less than equal 3 mm.Prior to the embolization with obsidio conformable embolic, the target vessel was not embolized with any other embolic agents.The renal artery (target vessel) was embolized using a non-boston scientific micro catheter with 0.1 ml of obsidio conformable embolic using aliquot technique.During the procedure, there was non-target embolization from the target vessel (renal artery) to the segmental renal arteries.The target vessel occluded within the expected area after embolization with obsidio embolic via angiography or demonstration of a cast of obsidio occluding the artery on fluoroscopy or other image acquisition.Post treatment with obsidio embolic, no other embolic agent was used.On (b)(6) 2025, during index procedure, the obsidio material refluxed out of the target vessel (renal artery) and embolized to non-target segmental renal arteries.Non-target migration was due to reflux.There was no physical issue of obsidio embolic, or difficulty in obsidio administration.The device deficiency was identified on angiogram.The subject was noted with mild self-limiting flank pain after non-target embolization.Obsidio was used per protocol.Following non-target embolization, the subject was kept under observation.The subject was in intermediate care post procedure (other than critical/intensive care or general floor care).The event did not lead to prolongation of index hospitalization.There was no other action taken for this event.The event has been reported as non-serious.At the time of the reporting, the outcome of the event was considered to be ongoing.On (b)(6) 2025, the subject was discharged from the hospital.

• 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): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23369649
• Report Number: 2124215-2025-75030
• Device Sequence Number: 13249353
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124(17)260203(10)35743210
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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 Expiration Date: 02/03/2026
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0035743210
• 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: 09/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 02/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: TERUMO PROGREAT
• Patient Sex: Unknown
• Patient Race: Black Or African American