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

Model Number	M001394240040150
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Device technical analysis: the returned device consists of an embold fibered with the delivery wire inserted in the delivery sheath and the perforations intact and the coil separated from the delivery system.Visual examination revealed a stretched and detached coil.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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as cause linked to device but unable to trace more specifically.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the coil would not advance through the sheath.A 4x15 embold fibered coil was selected for an embolization procedure.During the procedure, the coil would not advance through the sheath and kept getting stuck.Several attempts, to advance the coil, were made but none were successful.The coil was removed from the patient.An alternate device was used to complete the procedure.There were no patient complications as a result of this event.However, device analysis revealed the coil detached and separated from the delivery system.

• 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: 24971626
• Report Number: 2124215-2026-22123
• Device Sequence Number: 10428314
• Product Code: KRD
• UDI-Device Identifier: 08714729983576
• UDI-Public: (01)08714729983576(17)280522(10)36592755
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• 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): 04/23/2026

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: M001394240040150
• Device Catalogue Number: M001394240040150
• Device Lot Number: 0036592755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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
• Patient Sex: Unknown