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

Model Number	M001394240020040
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: as the event date was not available despite request by boston scientific (bsc), the event date was estimated to the first day of the aware month.D6a - implant date: as the implant date was not available despite request by bsc, the implant date was estimated to the first day of the aware month.
Event or Problem Description
It was reported that the coil was malpositioned.This 2x4 embold fibered device was selected for use in an embolization procedure to treat a bleed.It was noted the target location was moderately tortuous, and the vessel was not less than 1.5mm.After breaking the proximal release perforation, resistance was encountered when retracting the detachment (pull) wire.There was a delay in coil deployment, and the coil shifted slightly; however, the coil did not move into a different anatomical location and did not cause non-target embolization.The case was completed, and there were no patient complications as a result of this event.The patient fully recovered.

• 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: 23785252
• Report Number: 2124215-2025-88268
• Device Sequence Number: 17416428
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: (01)08714729983521(17)280828(10)37330185
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/11/2025

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: M001394240020040
• Device Catalogue Number: M001394240020040
• Device Lot Number: 0037330185
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 08/29/2025
• 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: Unknown