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

Model Number	M001394240060200
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Material Protrusion/Extrusion (2979); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: device history record (dhr) review: a ship history review for the reported upn was performed for the reporting customer.Batches (36946995), (36138268), and (35951146) were most recently shipped to the reporting facility in the 3-year period preceding the procedure date.There were no manufacturing deviations for any of the three batch numbers 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.
Event or Problem Description
It was reported that the coil migrated and required additional intervention.An embold? fibered 6x20 was selected for use to treat a splenic laceration.The embold coil was successfully deployed into the proximal splenic artery.Stasis was not achieved, so the physician followed it with a 45 cm non-boston scientific (bsc) packing coil.Before they fully deployed the non-bsc coil, the embold shot distally into the spleen.The physician resheathed the non-bsc packing and sent a snare to retrieve the embold.The physician was able to grab hold of the embold and pull it back all the way to the origin of the splenic artery, but was unable to retract it into the microcatheter.The physician reported some resistance and ultimately elected to leave the embold in the patient.The physician used embold 8x20 and non-bsc packing coils to block off the proximal splenic artery.Follow-up ct imaging revealed that the embold 6x20 had stretched all the way from the splenic artery to the access site in the right groin.The patient was started on baby aspirin and the physician ordered follow up imaging in a couple of months.There were no adverse patient symptoms 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; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25231150
• Report Number: 2124215-2026-27157
• Device Sequence Number: 17413656
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: (01)08714729983613
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: M001394240060200
• Device Catalogue Number: M001394240060200
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/20/2026
• 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 Sex: Unknown