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

Model Number	M0013972101010
Medical Device Problem Codes	Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that material separation occurred resulting in sequela of the non-target embolization.Obsidio was selected for an embolization procedure to treat a distal gastroduodenal artery (gda) bleed.During the procedure, 0.2ml of obsidio was delivered using the standard delivery technique.After injecting a significant cast of obsidio into the gda measuring 2.5mm, a large piece of the cast material dislodged and embolized more than one non-target distal liver vessels.A follow up computerized tomography (ct) scan was performed.Sequela of the non-target embolization to the hepatic arteries occurred.Obsidio conformable embolic was used to complete the procedure.There were no interventions and no patient complications.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.Good faith effort attempts were made to try and retrieve the device information and additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that material separation occurred resulting in sequela of the non-target embolization.Obsidio was selected for an embolization procedure to treat a distal gastroduodenal artery (gda) bleed.During the procedure, 0.2ml of obsidio was delivered using the standard delivery technique.After injecting a significant cast of obsidio into the gda measuring 2.5mm, a large piece of the cast material dislodged and embolized more than one non-target distal liver vessels.A follow up computerized tomography (ct) scan was performed.Sequela of the non-target embolization to the hepatic arteries occurred.Obsidio conformable embolic was used to complete the procedure.There were no interventions and no patient complications.It was further reported that the vessel was within vessel size range.Obsidio was not deployed to the origin of the gda.Upon removal of the microcatheter, obsidio fragmented and migrated a good distance distally into gastroepiploic.The physician clarified there was not non-target embolization to the hepatic arteries.Coils were placed to finish the embolization of the gda.
Additional Manufacturer Narrative
B5: describe event or problem: additional information correction to h6 patient codes (1): code updated from embolism/embolus to no clinical signs, symptoms or conditions correction to h6 impact codes (2): code serious injury/illness/impairment removed.B3: date of event: no date provided, used the first date in the month of the aware date.Good faith effort attempts were made to try and retrieve the device information and additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.Correction to date of event: updated from (b)(6) 2025 to (b)(6) 2025.D6a: implant date: populated date.A6: race: populated race.B7: other relevant history: added other relevant history.Good faith effort attempts were made to try and retrieve the device information and additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that material separation occurred resulting in sequela of the non-target embolization.Obsidio was selected for an embolization procedure to treat a distal gastroduodenal artery (gda) bleed.During the procedure, 0.2 ml of obsidio was delivered using the standard delivery technique.After injecting a significant cast of obsidio into the gda measuring 2.5 mm, a large piece of the cast material dislodged and embolized more than one non-target distal liver vessels.A follow up computerized tomography (ct) scan was performed.Sequela of the non-target embolization to the hepatic arteries occurred.Obsidio conformable embolic was used to complete the procedure.There were no interventions and no patient complications.It was further reported that the vessel was within vessel size range.Obsidio was not deployed to the origin of the gda.Upon removal of the microcatheter, obsidio fragmented and migrated a good distance distally into gastroepiploic.The physician clarified there was not non-target embolization to the hepatic arteries.Coils were placed to finish the embolization of the gda.It was further reported that prior to the embolization with obsidio embolic, the target vessel was not embolized with any other embolic agent.The target vessel was embolized using a non-boston scientific micro catheter.The target vessel occluded within the expected area after embolization with obsidio confirmed via angiography.On (b)(6) 2025, the subject was discharged.
Event or Problem Description
It was reported that material separation occurred resulting in sequela of the non-target embolization.Obsidio was selected for an embolization procedure to treat a distal gastroduodenal artery (gda) bleed.During the procedure, 0.2ml of obsidio was delivered using the standard delivery technique.After injecting a significant cast of obsidio into the gda measuring 2.5mm, a large piece of the cast material dislodged and embolized more than one non-target distal liver vessels.A follow up computerized tomography (ct) scan was performed.Sequela of the non-target embolization to the hepatic arteries occurred.Obsidio conformable embolic was used to complete the procedure.There were no interventions and no patient complications.It was further reported that the vessel was within vessel size range.Obsidio was not deployed to the origin of the gda.Upon removal of the microcatheter, obsidio fragmented and migrated a good distance distally into gastroepiploic.The physician clarified there was not non-target embolization to the hepatic arteries.Coils were placed to finish the embolization of the gda.It was further reported that prior to the embolization with obsidio embolic, the target vessel was not embolized with any other embolic agent.The target vessel was embolized using a non-boston scientific micro catheter.The target vessel occluded within the expected area after embolization with obsidio confirmed via angiography.On (b)(6) 2025, the subject was discharged.It was further reported that no device deficiency or adverse event occurred during the index procedure.Hence, complaint has been withdrawn for the same.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.

• 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: 21424962
• Report Number: 2124215-2025-09462
• Device Sequence Number: 20774364
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)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
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 01/23/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 04/24/2025; 05/29/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/05/2025; 05/21/2025; 06/26/2025
• 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: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White