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

Model Number	M001394240100500
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.The lot number was asked by the initial reporter but was unknown by the account/customer.Because the product 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.
Event or Problem Description
It was reported that the device broke requiring additional intervention.A 10x50 embold fibered was selected for use in a splenic embolization procedure.The vessel was moderately tortuous.During the procedure, it was noted that the coil was a little large.The device detached between the distal coupler and the coil during retraction.The proximal end of the coil stretched.Fragments of the stretched coil were left behind inside the patient.Once the physician saw the stretched coil, approximately an hour was spent trying to snare it out, but when it was snared, it would break apart.An angiogram revealed that the vessel was shut down; therefore, no further intervention was needed.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23715952
• Report Number: 2124215-2025-87924
• Device Sequence Number: 10275632
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: (01)08714729983651
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• 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): 12/04/2025

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: M001394240100500
• Device Catalogue Number: M001394240100500
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• 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
• Patient Sex: Unknown