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

Model Number	M001394240050150
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the coil prematurely deployed and an additional device was required.This 5x15 embold? fibered device was selected for use during a coronary artery fistula embolization procedure.During the procedure, the embold device was introduced into the microcatheter.During the delivery process, the device was unable to be advanced when one third of the coil remained, preventing further progression.Upon withdrawing the coil, it was found that the coil had become detached, and the coil remained in the main coronary artery.It was removed with a retrieval device, and a neuro coil was used to embolize and complete the procedure.There were no patient complications, and the patient condition was stable following the procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the coil prematurely deployed and an additional device was required.This 5x15 embold? fibered device was selected for use during a coronary artery fistula embolization procedure.During the procedure, the embold device was introduced into the microcatheter.During the delivery process, the device was unable to be advanced when one third of the coil remained, preventing further progression.Upon withdrawing the coil, it was found that the coil had become detached, and the coil remained in the main coronary artery.It was removed with a retrieval device, and a neuro coil was used to embolize and complete the procedure.There were no patient complications, and the patient condition was stable following the procedure.It was further reported that the coil was able to be passed approximately two thirds through the catheter before it could no longer advance, and resistance was also experienced upon withdrawal.The delivery wire broke near the distal coupler, and upon removal, both couplers remained on the delivery wire.Attempts had been made to remove the device and microcatheter as a whole; however, when removed, it was found that the coil was detached and remained in the coronary artery main trunk.

• 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: 23821000
• Report Number: 2124215-2025-91168
• Device Sequence Number: 18668097
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: (01)08714729983590(17)280521(10)36584911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001394240050150
• Device Catalogue Number: M001394240050150
• Device Lot Number: 0036584911
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/15/2026
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 54 KG