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

Model Number	M001394240020060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a break occurred.A 2x6 embold fibered was selected for use.During the procedure, other coils were deployed prior to the 2x6 embold fibered coil.A portion of the 2x6 embold fibered shaft was damaged and broke off alongside the coil.The device was removed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Good faith effort attempts were made to retrieve additional details regarding the reported event and the device status, but further information was unable to be obtained.Investigation results: device history records (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 statement: a risk review performed for the embold fibered 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 concludes the most probable root cause as 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 ; +1(952)930-6396
• MDR Report Key: 25472305
• Report Number: 2124215-2026-31243
• Device Sequence Number: 21439068
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: (01)08714729983538(17)280202(10)35763307
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001394240020060
• Device Catalogue Number: M001394240020060
• Device Lot Number: 0035763307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 02/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown