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

Model Number	M001394240100500
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	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consists of embold fibered with the coil in the delivery sheath and the perforations intact.The device was examined visually and microscopically to reveal a stretched coil in the delivery sheath and coil separated from the coupler.
Event or Problem Description
Reportable based on device analysis completed on 24jun2025.It was reported that premature deployment occurred.The non-stenosed target lesion was located in a severely tortuous and mildly calcified internal iliac artery.An embold fibered 10x50 was selected to treat an aortic aneurysm.There was resistance when inserting the coil, so it was withdrawn and flushed with saline once.Then it was reinserted, but the resistance did not resolve.The coil was removed with the breakthrough 2marker microcatheter and checked, and it had appeared to be detached within the middle part of the microcatheter.The procedure was then completed with a different model.There were no patient complications as a result of this event.However, device analysis revealed a coil break.

• 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: 22522070
• Report Number: 2124215-2025-41605
• Device Sequence Number: 8078475
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: (01)08714729983651(17)270614(10)34247824
• 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): 07/16/2025

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: M001394240100500
• Device Catalogue Number: M001394240100500
• Device Lot Number: 0034247824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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