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

Model Number	M001394240140300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction

• 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; business and technology park,; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50569942
• Report Number: 2124215-2026-46622
• Device Sequence Number: 18656317
• Product Code: KRD
• UDI-Device Identifier: 08714729983705
• UDI-Public: (01)08714729983705(17)310126(10)38446524
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: M001394240140300
• Device Catalogue Number: M001394240140300
• Device Lot Number: 0038446524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/27/2026
• 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