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

Model Number	M0013972101010
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Infusion or Flow Problem (2964); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that insufficient formation of the obsidio embolic occurred, requiring an additional device.This obsidio conformable embolic was selected for use during a retroperitoneal embolization procedure.The target vessel was located in the low, distal left side of retroperitoneum and the vessel size was 1-2mm per the physician.During the procedure, the physician was at the distal vessel they wished to embolize and used a truselect 130cm microcatheter.The obsidio conformable embolic was attached to the microcatheter using wet-to-wet technique.The physician started injecting and after filling the dead space of the microcatheter, no obsidio was visualized under fluoroscopy.At this point, there was roughly estimated approximately.3ccs of obsidio left in the syringe.It was noted that the flow of obsidio was smooth when injected; however, when it got to the end, it was harder.It was attempted to inject the remainder of the embolic, but it was getting significantly harder to inject.The microcatheter was removed and replaced with a new one to do a hand contrast run.Once performed, there seemed to be no product visualized anywhere in the patient.No embolization had taken place and there was still blood flow to the vessel.A penumbra ruby low profile coil was placed as an alternative to the conformable embolic.Following this, outside the patient at the back table, an attempt was made to flush the first catheter used for obsidio to see if any would come out and none was able to come out of the microcatheter.Some of the product was removed from the hub of the microcatheter and placed on the table, and the consistency seemed to be more clay like material than soft gel.The remainder less than 0.1cc in the syringe was also pushed out onto the table, which also was a changed, dehydrated consistency.There were no patient complications as a result of this event.

• 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: 23595794
• Report Number: 2124215-2025-82876
• Device Sequence Number: 18475897
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124(17)260708(10)36913879
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/19/2025

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: 07/08/2026
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0036913879
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 07/08/2025
• 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: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Race: White