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

Model Number	M001394240020060
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was taken to the or for emergent angiogram/embolization.During attempted embolization of a small cortical branch artery, a boston scientific embold detachable fibered coil deployed and unraveled unexpectedly.This prompted a prolonged procedure to remove a portion of the unraveled coil.Ultimately a long portion of it was removed, however a small unraveled fiber was unable to be removed.

• Brand Name: EMBOLD¿ FIBERED
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 22951598
• Report Number: 22951598
• Device Sequence Number: 9867777
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: (01)08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/22/2025
• Report Date (Section F): 08/22/2025

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: M01394240020060
• Device Lot Number: 36059604
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/22/2025