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

Model Number	M001394240050150
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.An embold? fibered was selected for use in the embolization procedure to treat a bleed in an aneurysm.During the procedure, after a couple of loops were formed within the vessel, there was resistance encountered when advancing the coil within the non-boston scientific microcatheter.The coil was retracted back, but resistance was again encountered.The couple of loops that had formed within the vessel were not retracting back into the microcatheter, so the microcatheter and coil were removed as a unit.A portion of the coil was protruding from the tip of the microcatheter during withdrawal, and the coil was stretched.Another coil was used in the microcatheter without issue.The procedure was completed with the alternate device, and there were no patient complications as a result of this event.However, device analysis revealed that the coil broke from the distal coupler while the couplers were still connected.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the returned device consisted of an embold fibered delivery system with the perforations intact.The coil was not returned.The device was examined microscopically to reveal that the coil had broke from the distal coupler while the couplers were connected.Due to the incomplete device return, it was not possible to confirm the additional allegations of coil stretch, coil stuck in tip of the catheter, and/or difficult to advance and withdraw device.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 risk review performed for the embold 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 failure to follow instructions.The user reported using the device with intermittent flushing.The ifu identifies the importance of maintaining a continuous flush during use of the embold device.

• 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: 24820343
• Report Number: 2124215-2026-19130
• Device Sequence Number: 15841849
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: (01)08714729983590(17)270925(10)34925377
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/08/2026

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: M001394240050150
• Device Catalogue Number: M001394240050150
• Device Lot Number: 0034925377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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