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

Model Number	M001394240100200
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device analysis findings: the returned device consisted of an embold fibered coil without the delivery wire and distal coupler.The coil was returned inserted in a non-boston scientific microcatheter with a segment of the coil protruding out of the distal tip of the microcatheter.Visual examination revealed a stretched coil.X-ray imaging revealed a coil separation from distal coupler while in the non-bsc microcatheter.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 has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
Reportable based on device analysis completed on 08jun2026.It was reported that premature deployment occurred.A 10x20 embold fibered was selected for an embolization procedure.The coil was difficult to advance and deployed in the catheter before 25 percent of the coil was deployed.There were no patient complications as a result of this event.An alternate device was used to complete the procedure.However, device analysis revealed coil separation from the distal coupler.

• 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25738424
• Report Number: 2124215-2026-36111
• Device Sequence Number: 10459398
• Product Code: KRD
• UDI-Device Identifier: 08714729983637
• UDI-Public: (01)08714729983637(17)280708(10)36930489
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 08/04/2026

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: M001394240100200
• Device Catalogue Number: M001394240100200
• Device Lot Number: 0036930489
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2026
• 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: 06/08/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown