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

Model Number	M001394240100300
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.A 10x30 embold fibered was selected for an embolization procedure of sma.During removal from the hoop, the coil sprang loose and was contaminated on a monitor.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24119921
• Report Number: 2124215-2026-03629
• Device Sequence Number: 20352557
• Product Code: KRD
• UDI-Device Identifier: 08714729983644
• UDI-Public: (01)08714729983644(17)280918(10)37493806
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/20/2026

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: M001394240100300
• Device Catalogue Number: M001394240100300
• Device Lot Number: 0037493806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 09/19/2025
• 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: Male