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

Model Number	M001394240050150
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G1: mfr site zip/post code: t12 yk88.
Event or Problem Description
It was reported in a medwatch report that premature deployment in an unintended location occurred, requiring additional intervention.A 5x15 embold fibered was selected for use in a y90 embolization procedure to treat liver cancer.The embold fibered coil prematurely deployed into an unintended location, during repositioning of the coil.The embold fibered coil protruded from the intended target located after deployment.Two different snares were required in numerous attempts to remove the entire coil from the patient, which extended the procedure time.There were no patient complications as a result of this event.
Event or Problem Description
It was reported in a medwatch report that premature deployment in an unintended location occurred, requiring additional intervention.A 5x15 embold fibered was selected for use in a y90 embolization procedure to treat liver cancer.The embold fibered coil prematurely deployed into an unintended location, during repositioning of the coil.The embold fibered coil protruded from the intended target located after deployment.Two different snares were required in numerous attempts to remove the entire coil from the patient, which extended the procedure time.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G1: mfr site zip/post code: t12 yk88.Investigation results: device technical analysis: upon receipt at out post market quality assurance laboratory, this embold fibered coil returned in a catheter and microcatheter tip section, was examined.The embold delivery system was not returned along with the proximal end of the guide catheter and microcatheter.Visual examination revealed a stretched coil.X-ray imaging revealed a broken coil in the catheter system.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 risk review performed for the embold fibered device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have 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.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24457841
• Report Number: 2124215-2026-10796
• Device Sequence Number: 18679026
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: (01)08714729983590(17)281014(10)37707098
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 0037707098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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 Sex: Unknown