MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD? Fibered; Device, Vascular, For Promoting Embolization

Model Number	M001394240040150
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Stretched (1601); Malposition of Device (2616); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil detached requiring intervention, and there were unretrieved device fragments.A 4mm x 15cm embold? fibered coil was selected for use in an embolization procedure to treat a bleed.The vessel was mildly tortuous.During the procedure, difficulty advancing was noted, and the coil detached and fell apart in the 130cm truselect microcatheter while the coil was half in the vasculature and half in the microcatheter.The proximal release perforation was not broken.The coil was deployed into the gastroduodenal artery (gda) while prolapsing into the common, proper and right hepatic arteries, which it subsequently thrombosed.Most of the coil was retrieved with a snare, but there was a stringy portion that was coming off the end of it and detached.Most of that portion was retrieved too, but it was too late for the common hepatic, proper hepatic, and gda, which were all completely thrombosed.The majority of the device fragments were removed during the procedure, and there is no plan to remove any fragments that remain.It was also noted that the procedure was aborted because of diffuse vessel thrombosis / dissection.The patient was in stable condition and discharged.
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot # is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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 ; +1(952)930-6396
• MDR Report Key: 50168455
• Report Number: 2124215-2026-42330
• Device Sequence Number: 10032757
• Product Code: KRD
• UDI-Device Identifier: 08714729983576
• UDI-Public: (01)08714729983576
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: M001394240040150
• Device Catalogue Number: M001394240040150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 77 YR
• Patient Sex: Unknown