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

Model Number	M0013972101010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an abscess occurred.Obsidio was used in an embolization procedure to treat a bleed in the retroperitoneal space.The standard delivery method was used to deliver the obsidio to the target location.An infection was noted in a vessel in the retroperitoneal space, resulting in an abscess.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.

• 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: 21313744
• Report Number: 2124215-2025-05025
• Device Sequence Number: 8169405
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/05/2025

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?: No
• 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: 01/09/2025
• Initial Report FDA Received Date: 02/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown