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

Model Number	M001394240200500
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consists of embold fibered coil and a microcatheter.The device was examined visually and microscopically to reveal that the coil was separated at the couplers.The microcatheter was x-rayed and it revealed that the coil was stuck inside the microcatheter.It appeared to have bunched while inserted into the catheter.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 16sep2025.It was reported that the proximal release was difficult to break.An embold fibered 20x50 was selected for a balloon-occluded retrograde transvenous obliteration (brto) procedure in the gastrorenal shunt.When attempting to deploy the coil, however, the proximal release could not be detached whether it was bent or pulled.A new coil of a different model was used to complete the procedure.There were no patient complications as a result of this event.However, device analysis revealed that the coil was separated at the couplers.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23299999
• Report Number: 2124215-2025-72050
• Device Sequence Number: 4786970
• Product Code: KRD
• UDI-Device Identifier: 08714729983736
• UDI-Public: (01)08714729983736(17)271220(10)35531427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: M001394240200500
• Device Catalogue Number: M001394240200500
• Device Lot Number: 0035531427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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