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

Model Number	M001394240180500
Medical Device Problem Codes	Break (1069); Stretched (1601); Separation Failure (2547); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: media review: media was received in the form of images.The media submitted with the complaint has been thoroughly examined and evaluated to reveal a broken and stretched coil while another image appears to be an x-ray reference of the procedure.The reported event was confirmed through review of the images the site provided.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the embold? fibered was completed and confirmed that the event of coil break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported that internal device fracture occurred requiring intervention.An 18x50 embold? fibered was selected for pulmonary embolization to treat an aneurysm.During the procedure, however, it was noted that the coil moved slowly through the renegade and non-boston scientific microcatheters.When deploying the coil, the coil was not able to detach or retract.The coil became stuck, so it had to be removed with a snare.While removing the coil, it broke into multiple pieces.The device was explanted, and there were no patient complications as a result of the event.The patient fully recovered after the procedure.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24981018
• Report Number: 2124215-2026-22279
• Device Sequence Number: 13186274
• Product Code: KRD
• UDI-Device Identifier: 08714729983729
• UDI-Public: (01)08714729983729(17)280127(10)35715729
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M001394240180500
• Device Catalogue Number: M001394240180500
• Device Lot Number: 0035715729
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown