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

Model Number	M0013972101010
Medical Device Problem Codes	Material Separation (1562); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that material separation occurred.Obsidio was selected for a renal embolization procedure.Obsidio was injected into an upper pole renal branch.The physician began refluxing into the 155cm truselect bern microcatheter.Within approximately 20-30 seconds of the catheter being occlusive, obsidio refluxed, and the microcatheter was pulled back.While pulling back the microcatheter, approximately 1cm of obsidio was noticed on the distal portion of the microcatheter.An attempt was made to let the catheter sit near the proximal portion of the obsidio 'pack' to see if the blood flow would take the material off the catheter, which did not work.The microcatheter was quickly pulled out and while doing so, the 1cm of obsidio was still on the catheter tip eventually sheared off and went into a lower pole renal branch and eventually fragmented into pieces, which went into multiple branches within the kidney.There were no patient complications as a result of the event and the patient is expected to fully recover.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.Investigation results: media review: media was received in the form of imagery of what appears to be a scan of obsidio conformable embolic occluding multiple vessel branches.However, due to insufficient medical imaging training, it was unable to be determined by the investigator if the reported event was confirmed based on the provided images.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described with this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the obsidio device confirmed that the reported events are known events defined in the products risk documentation.This event has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported that material separation occurred.Obsidio was selected for a renal embolization procedure.Obsidio was injected into an upper pole renal branch.The physician began refluxing into the 155cm truselect bern microcatheter.Within approximately 20-30 seconds of the catheter being occlusive, obsidio refluxed, and the microcatheter was pulled back.While pulling back the microcatheter, approximately 1cm of obsidio was noticed on the distal portion of the microcatheter.An attempt was made to let the catheter sit near the proximal portion of the obsidio 'pack' to see if the blood flow would take the material off the catheter, which did not work.The microcatheter was quickly pulled out and while doing so, the 1cm of obsidio was still on the catheter tip eventually sheared off and went into a lower pole renal branch and eventually fragmented into pieces, which went into multiple branches within the kidney.There were no patient complications as a result of the event and the patient is expected to fully recover.It was further reported that the vessel size was under 3mm.The delivery technique was standard using a.021 inner diameter truselect bern microcatheter.No intervention was required.

• 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: 24075993
• Report Number: 2124215-2026-02667
• Device Sequence Number: 15799589
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124(17)260818(10)37229569
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/01/2026

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 Expiration Date: 08/18/2026
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0037229569
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 08/18/2025
• 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: Male