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	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an abscess occurred requiring intervention.The subject underwent index procedure on (b)(6) 2025 and was enrolled into the study on (b)(6) 2025.The target lesion was located in the splenic artery with a vessel diameter of 4 mm.The aneurysm was not bleeding.The location was distal near the hilum and not amenable for treatment with stent graft.It had two inflows measuring approximately 4 mm each which were targeted.Access was tortuous.Prior to the embolization with obsidio conformable embolic, one vessel was embolized with three non-boston scientific retractable coils to backstop the embolization in the distal portion of target location.In the other vessel only obsidio was used as flow was fairly stagnant.Aliquot technique was used for both.A total of approximately 0.5 ml (half of one syringe) of obsidio was used, it was estimated about 0.2 ml in the branch with coils and 0.3 ml in the other branch using a non-boston scientific microcatheter.It was noted that short gastrics did not fill in supply following embolization and only one small branch was left to supply the spleen.Post treatment with obsidio embolic, no other embolic agent was used.Patient was observed for about three days in the hospital and was given vaccines and antibiotics were given.On (b)(6) 2025, 35 days post index procedure, subject returned to another facility and was noted with splenic abscess.The patient remained admitted to the hospital since (b)(6) 2025.A percutaneous and a splenic abscess drain were placed.Post drain placement, subject received iv antibiotics.
Event or Problem Description
It was reported that an abscess occurred requiring intervention.The subject underwent index procedure on (b)(6) 2025 and was enrolled into the study on (b)(6) 2025.The target lesion was located in the splenic artery with a vessel diameter of 4 mm.The aneurysm was not bleeding.The location was distal near the hilum and not amenable for treatment with stent graft.It had two inflows measuring approximately 4 mm each which were targeted.Access was tortuous.Prior to the embolization with obsidio conformable embolic, one vessel was embolized with three non-boston scientific retractable coils to backstop the embolization in the distal portion of target location.In the other vessel only obsidio was used as flow was fairly stagnant.Aliquot technique was used for both.A total of approximately 0.5 ml (half of one syringe) of obsidio was used, it was estimated about 0.2 ml in the branch with coils and 0.3 ml in the other branch using a non-boston scientific microcatheter.It was noted that short gastrics did not fill in supply following embolization and only one small branch was left to supply the spleen.Post treatment with obsidio embolic, no other embolic agent was used.Patient was observed for about three days in the hospital and was given vaccines and antibiotics were given.On (b)(6) 2025, 35 days post index procedure, subject returned to another facility and was noted with splenic abscess.The patient remained admitted to the hospital since (b)(6) 2025.A percutaneous and a splenic abscess drain were placed.Post drain placement, subject received iv antibiotics.It was further reported that the feeding vessel number 1 of the splenic artery was embolized using a non-boston scientific microcatheter with 0.5 ml of obsidio conformable embolic using aliquot technique.The feeding vessel number 2 of the splenic artery was embolized using a non-boston scientific microcatheter with 0.3 ml of obsidio conformable embolic using aliquot technique.There were two branches to the spleen that were feeding the splenic aneurysm.On (b)(6) 2025, the subject was discharged home.

• 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: 22020562
• Report Number: 2124215-2025-30798
• Device Sequence Number: 12967627
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124(17)251021(10)35106550
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Report Date (Section B): 10/14/2025

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 Expiration Date: 10/21/2025
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0035106550
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 10/21/2024
• 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: COILS: CONCERTO RETRACTABLE; COILS: CONCERTO RETRACTABLE; MICROCATHETER: TERUMO - PROGREAT; MICROCATHETER: TERUMO - PROGREAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Race: White