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

Model Number	M0013972101010
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that material migration and separation occurred resulting in non target embolization.Obsidio was selected for use in a type 2 endoleak embolization procedure.The 4cm endoleak sac was accessed under computed tomography (ct) guidance using two accustick cannulas.The patient was brought to the fluoroscopy room and contrast was injected through a 2.8 non-boston scientific microcatheter.Contrast appeared to stain the sack but did not leave the aneurysmal sac.The microcatheter was then flushed with normal saline and obsidio was connected and injected into the aneurysmal sac.The entire first syringe was injected without issue.Visualization was good and obsidio was seen filling the sac.The second syringe was connected to the microcatheter and obsidio was injected to the sack.Obsidio was injected using standard delivery.About halfway through the injection, obsidio started to fill the inferior mesenteric artery which was approximately 3 to 3 1/2 millimeters in diameter.A large column of obsidio filled the inferior mesenteric artery (ima) but never stopped moving and continued to flow distally, eventually splitting into smaller pieces and embedding themselves within the distal colic branches.The remaining flow was embolized using coils.The accusticks were removed and the patient was sent to ct for an abdominal angiogram.The were no patient complications and the patient was discharged home.
Additional Manufacturer Narrative
A2: age at time of event: over the age of 18.

• 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; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21662135
• Report Number: 2124215-2025-17243
• Device Sequence Number: 8272586
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 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): 03/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0000318241
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 03/18/2024
• 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: 2.8 PROGREAT.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male