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

Model Number	M001394240100500
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: the returned device consisted of an embold? fibered with the perforations intact and the coil broken from the coupler.The device was examined microscopically to reveal a stretched coil that broke from the coupler, with both couplers bent and held in place by the delivery wire and pull wire.
Event or Problem Description
It was reported that the coil stretched and broke within the patient.An embold? fibered was selected for use in an endovascular aneurysm repair (evar) procedure in the left internal iliac artery.A non-boston scientific microcatheter was inserted via the contralateral approach, and the coil was positioned and deployment was initiated by breaking the proximal release perforation.When approximately 5 cm of the coil remained to be deployed, the coil began to stretch.The microcatheter was carefully withdrawn from the lesion to prevent the coil from deploying fully.As the microcatheter was pulled, the stretched portion of the coil broke off within the patient.The microcatheter and majority of the coil were withdrawn from the patient.Retrieval of the detached portion of the coil would have proved difficult due to a tortuous anatomy, so the physician elected to use a planned stent graft to press the remaining portion of the coil into place.No additional intervention was required.There were no adverse events as a result of the 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24121704
• Report Number: 2124215-2026-03663
• Device Sequence Number: 9689516
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: (01)08714729983651(17)270819(10)34666681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: M001394240100500
• Device Catalogue Number: M001394240100500
• Device Lot Number: 0034666681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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