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

Model Number	M001394250040300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Material Protrusion/Extrusion (2979); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient details were unavailable per the account.
Event or Problem Description
It was reported that the coil fractured internally, requiring additional intervention and resulting in an unretrieved device fragment in an unintended location.An embold soft 4x30 was selected for use to treat a splenic bleed.During the procedure, the coil fractured and unraveled in portions of the main splenic artery and inside the base non-boston scientific catheter.Numerous attempts were made to snare the tiny filament but were unsuccessful.The unraveled micro coil was found to extend into the distal abdominal aorta, just above the bifurcation to the iliac arteries.The physician was able to capture the filament with a snare, but the filament broke further up the aorta.The physician was then able to remove a long segment of the filament but failed to grab the small filament after multiple attempts.A small filament of the coil was ultimately left within the patient.The patient was expected to fully recover.
Event or Problem Description
It was reported that the coil fractured internally, requiring additional intervention and resulting in an unretrieved device fragment in an unintended location.An embold soft 4x30 was selected for use to treat a splenic bleed.During the procedure, the coil fractured and unraveled in portions of the main splenic artery and inside the base non-boston scientific catheter.Numerous attempts were made to snare the tiny filament but were unsuccessful.The unraveled micro coil was found to extend into the distal abdominal aorta, just above the bifurcation to the iliac arteries.The physician was able to capture the filament with a snare, but the filament broke further up the aorta.The physician was then able to remove a long segment, but failed to grab the small filament after multiple attempts.A small filament of the coil was ultimately left within the patient.The patient was expected to fully recover.It was further reported that prior to the coil fracturing, there was difficulty encountered retracting the coil into the microcatheter.
Additional Manufacturer Narrative
Patient details were unavailable per the account.Investigation results: 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 unable to exclude device problem.

• Brand Name: EMBOLD? SOFT
• 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: 24416522
• Report Number: 2124215-2026-09880
• Device Sequence Number: 13413108
• Product Code: KRD
• UDI-Device Identifier: 00191506026479
• UDI-Public: (01)00191506026479(17)281005(10)37626913
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: M001394250040300
• Device Catalogue Number: M001394250040300
• Device Lot Number: 0037626913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 10/06/2025
• 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; Other
• Patient Sex: Unknown