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

Model Number	M001394240140500
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis findings: upon receipt at our post market quality assurance laboratory, this embold fibered coil was examined.The delivery system was not returned.The device was examined visually and microscopically to reveal a stretched and kinked coil.The reported event was confirmed.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 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 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 unintended use error caused or contributed to event.
Event or Problem Description
It was reported that the coil was surgically removed.A 14x50 embold? fibered device was utilized for an embolization procedure on a moderately tortuous subclavian artery with a target vessel diameter of approximately 10mm.This embold coil was used for the first embolization and was believed to have been deployed.Subsequently, another embold coil and a packing coil were inserted.It was then noticed that the first embold coil had unraveled or stretched at its midpoint and was sticking out from the microcatheter.It was suspected that the coil may have been pulled into the microcatheter before it had fully detached.Since placement inside the body was no longer possible, all coils were removed surgically via incision of the subclavian artery, and the procedure was discontinued.No patient complications occurred as a result of this event.

• 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: 24955478
• Report Number: 2124215-2026-21739
• Device Sequence Number: 10084710
• Product Code: KRD
• UDI-Device Identifier: 08714729983712
• UDI-Public: (01)08714729983712(17)280326(10)36171169
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: M001394240140500
• Device Catalogue Number: M001394240140500
• Device Lot Number: 0036171169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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