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

Model Number	M0013972101010
Medical Device Problem Codes	Material Separation (1562); Activation, Positioning or Separation Problem (2906); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that material separation occurred resulting in embolization of an unintended location.Obsidio was selected for several bleeds and kidney embolization procedures.It was noted that when using obsidio in small 1 to 2mm sized vessels, it is unpredictable and does not form as it should.Proper injection techniques were applied.The speed of the injections was average.The obsidio flowed forward and flexed.Fragmentation of obsidio occurred resulting in embolization of an unintended location.There were no patient complications.
Additional Manufacturer Narrative
This report is being submitted as a correction to remove the device code of infusion or flow problem in h6: device codes (2).B3: date of event: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that material separation occurred resulting in embolization of an unintended location.Obsidio was selected for several bleeds and kidney embolization procedures.It was noted that when using obsidio in small 1 to 2mm sized vessels, it is unpredictable and does not form as it should.Proper injection techniques were applied.The speed of the injections was average.The obsidio flowed forward and flexed.Fragmentation of obsidio occurred resulting in embolization of an unintended location.There were no patient complications.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.B3: date of event: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that material separation occurred resulting in embolization of an unintended location.Obsidio was selected for several bleeds and kidney embolization procedures.It was noted that when using obsidio in small 1 to 2mm sized vessels, it is unpredictable and does not form as it should.Proper injection techniques were applied.The speed of the injections was average.The obsidio flowed forward and flexed.Fragmentation of obsidio occurred resulting in embolization of an unintended location.There were no patient complications.It was further reported that obsidio was used for a gastrointestinal (gi) bleed using standard technique.Additionally, the physician stated that obsidio "shoots out" at fast injections causing a more distal ischemia.

• 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: 20958599
• Report Number: 2124215-2024-79895
• Device Sequence Number: 15502663
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 05/08/2025

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 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: 11/19/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 04/11/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/29/2025; 05/08/2025
• 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