MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD? Fibered; Device, Vascular, For Promoting Embolization

Model Number	M001394240200500
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the previously deployed coil was pulled out of position, and intervention was required to correct its position.Two 20mm x 50cm embold? fibered coils were selected for use in the embolization of a splenic artery aneurysm.Other non-boston scientific coils were also used in the procedure.The microcatheter was flushed immediately prior to coil insertion, and continuous flushing was performed throughout the procedure.During the procedure, resistance was felt during coil placement.An attempt was made to retrieve the coil; however, the coil became unraveled, making retrieval impossible.An attempt was made to withdraw the coil together with the microcatheter; however, the previously deployed coil, another 20mm x 50cm embold.Fibered coil, also moved.It might have been the coil that caught on the previously deployed coil.As a result, retrieval was unsuccessful.The unraveled coil was secured with a balloon and cut outside the body.The cut end was pushed into the aneurysm using another coil, resulting in a portion of the coil remaining in the body.The previously deployed coil moved out of position, partially in the target vessel and partially protruding out of the target vessel.Since framing was successful with embold, a stent from another manufacturer was placed within the same aneurysm, and the previously deployed coil's position was corrected and now fully contained in the target vessel.The procedure was completed successfully.There were no patient complications as a result of this event, and no changes in the patient's condition.

• Brand Name: EMBOLD? Fibered
• Common Device Name: Device, Vascular, For Promoting Embolization
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; business and technology park,; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50889517
• Report Number: 2124215-2026-50993
• Device Sequence Number: 10704982
• Product Code: KRD
• UDI-Device Identifier: 08714729983736
• UDI-Public: (01)08714729983736(17)280918(10)37493840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: M001394240200500
• Device Catalogue Number: M001394240200500
• Device Lot Number: 0037493840
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 09/19/2025
• 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 Sex: Unknown