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

Model Number	M001394250020020
Medical Device Problem Codes	Malposition of Device (2616); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that malposition of the device occurred.An embold soft 2x2 coil was selected for an embolization procedure for a lower gastrointestinal bleed.The coil was deployed; however, after attempted detachment, the coil was adherent to the pusher wire.Multiple maneuvers were attempted to retract the coil inside the microcatheter (truselect 130cm) but were not successful.The decision was made to attempt to retract the coil and microcatheter together until externalized.Once the microcatheter and coil contacted the base catheter, the coil detached and migrated down to the ileocolic artery.A superior mesenteric arteriogram was performed via the base catheter, showing the coil in a distal branch of the ileocolic artery; however, no evidence of decreased flow to the ileocolic segment was noted.No further products were used after the fact.The patient blood pressure was stabilized and pressor support was discontinued.The patient left the department in stable condition with no complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device history record 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 review of the embold device was completed and confirmed that the reported event was defined in the risk documentation.This event type has 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: 25088275
• Report Number: 2124215-2026-24358
• Device Sequence Number: 10395371
• Product Code: KRD
• UDI-Device Identifier: 00191506026363
• UDI-Public: (01)00191506026363(17)270404(10)33757171
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• 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): 05/05/2026

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: M001394250020020
• Device Catalogue Number: M001394250020020
• Device Lot Number: 0033757171
• 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: 04/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 04/04/2024
• 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