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

Model Number	M001394240020040
Medical Device Problem Codes	Break (1069); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil stretched and broke within the patient.An embold fibered 2x4 was selected for use to treat a bleed in the lower gastrointestinal tract.The target lesion was located within a less than 2mm vessel.During the procedure, the coil and a tiny fragment of the coil wire detached in the patient.The portion of the coil remained implanted, and there was no report of additional intervention.The physician stated there was no harm caused to the patient.No further information was provided despite request by boston scientific.
Event or Problem Description
It was reported that the coil stretched and broke within the patient.An embold fibered 2x4 was selected for use to treat a bleed in the lower gastrointestinal tract.The target lesion was located within a less than 2mm vessel.During the procedure, the coil and a tiny fragment of the coil wire detached in the patient.The portion of the coil remained implanted, and there was no report of additional intervention.The physician stated there was no harm caused to the patient.No further information was provided despite request by boston scientific.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the returned device consisted of an embold fibered delivery system with the perforations broken.The delivery sheath, pull wire, coil, and the proximal detachment end were not returned.Microscopical examination revealed a polymer shaft kink located approximately 0.5 cm from the proximal coupler.Device history record (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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a review of the embold device confirmed that the reported event is a known event defined in the product's risk management 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".The reported information and device analysis do not clearly indicate a cause of the reported issue.

• 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: 23864544
• Report Number: 2124215-2025-92288
• Device Sequence Number: 13113906
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: (01)08714729983521(17)280601(10)36655611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/18/2026

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: M001394240020040
• Device Catalogue Number: M001394240020040
• Device Lot Number: 0036655611
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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