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

Model Number	M001394240140500
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: review of the embold device confirmed that the reported event is a known event defined in the product's risk management 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 cause not established.
Event or Problem Description
It was reported that the coil migrated, and additional intervention was required.An embold fibered 14x50 was selected for use in an ovarian vein embolization to treat pelvic congestion.The target lesion was mildly calcified and tortuous.The coil was used along with a 2.8 non-boston scientific microcatheter.Prior to use of this coil, a 12x30 coil was deployed with no issues.The resident began deploying the complaint device until resistance was met, then was unable to advance at least 30 cm of coil out of the microcatheter.The microcatheter was pulled back, and the physician attempted to give the coil more space to deploy, but deployment was unsuccessful.At this time, the resident began to retract the coil, and the coil would not move.The resident ended up retracting both the microcatheter and the coil, which was protruding from the tip of the microcatheter.The coil then migrated higher up and deployed while trying to remove the microcatheter.The resident used a snare to retrieve the coil, a process which took 3.5 hours.In the end, the procedure was aborted without implanting an additional coil.There were no patient complications as a result of this 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24674471
• Report Number: 2124215-2026-16015
• Device Sequence Number: 10139819
• Product Code: KRD
• UDI-Device Identifier: 08714729983712
• UDI-Public: (01)08714729983712(17)271203(10)35406459
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 03/24/2026

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: M001394240140500
• Device Catalogue Number: M001394240140500
• Device Lot Number: 0035406459
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 12/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown