MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD? FIBERED; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001394240060200
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil fractured, resulting in an unretrieved device fragment.An embold? fibered 6x20 was selected for use to treat an abdominal aortic aneurysm along with a truselect microcatheter.Prior to use of the embold device, a non-boston scientific liquid embolic agent was used to treat the lesion.The target vessel was reported to be tortuous.During the procedure, while positioning and deploying the coil in the proximal inferior mesenteric artery, there was resistance encountered in the coil detachment system.As a result, the coil fractured, with a fragment of the coil breaking off within the patient.Several attempts were made to retrieve the coil fragment using an unknown 4mm micro-snare, but attempts were unsuccessful.The physician was unable to retrieve the coil fragment, which was observed proximally at the level of the left colic artery, outside of the target lesion.No further intervention was reported.
Additional Manufacturer Narrative
Investigation results: device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the embold device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.

• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25350626
• Report Number: 2124215-2026-29161
• Device Sequence Number: 13373085
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: (01)08714729983613(17)310126(10)38446516
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: M001394240060200
• Device Catalogue Number: M001394240060200
• Device Lot Number: 0038446516
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 01/27/2026
• 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