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

Model Number	M001394240120300
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 07apr2026.The returned device evaluation revealed the coil was detached from the distal coupler.A 12x30 embold? fibered device was used during a left subclavian embolization procedure to treat a bleed.The coil would not frame the way the surgeon wanted during deployment; therefore, the surgeon retracted and advanced the coil multiple times before withdrawing the coil.On final withdrawal, resistance was noted, and the coil formed a knot, and the coil was unable to be advanced or retracted into the microcatheter.The coil stretched as the surgeon attempted to pull it through the microcatheter.The coil and catheter were removed as there was a long line of filament due to the stretch.The bleeding was stopped using two clips, and the patient experienced no complications.
Additional Manufacturer Narrative
Investigation results: device analysis findings: upon receipt at our post market quality assurance laboratory, this embold fibered delivery system was returned without the delivery sheath and the perforations intact.A renegade stc and non-bsc guide catheter were also returned with the embold fibered device.Visual and microscopic examination revealed a stretched coil extending through the microcatheter and guide catheter.Microscopic examination revealed bent proximal and distal couplers, and coil separation from the distal 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 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.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.

• 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: 24984581
• Report Number: 2124215-2026-22356
• Device Sequence Number: 10451392
• Product Code: KRD
• UDI-Device Identifier: 08714729983675
• UDI-Public: (01)08714729983675(17)280708(10)36930495
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001394240120300
• Device Catalogue Number: M001394240120300
• Device Lot Number: 0036930495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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