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

Model Number	M001394240030120
Medical Device Problem Codes	Break (1069); Material Protrusion/Extrusion (2979); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the coil fractured and portions of it were snared from the patient.A fractured portion of the coil extended into a non-target location.An embold? fibered was selected for use to treat an embolic fistula during a y-90 mapping procedure.The coil passed through a truselect microcatheter to reach the target lesion.When the proximal release perforation was snapped, it appeared that a filament remained attached to the coil, and broke off proximally.Portions of the coil were snared out of the patient.The coil was in place in the target lesion, but part of the filament extended down into the aorta.There was no further intervention reported, and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.Device analysis: the returned device consisted of embold fibered delivery wire with perforations broken.The device was examined microscopically to reveal a bent distal coupler.No further device deficiencies were observed.
Event or Problem Description
It was reported that the coil fractured and portions of it were snared from the patient.A fractured portion of the coil extended into a non-target location.An embold? fibered was selected for use to treat an embolic fistula during a y-90 mapping procedure.The coil passed through a truselect microcatheter to reach the target lesion.When the proximal release perforation was snapped, it appeared that a filament remained attached to the coil, and broke off proximally.Portions of the coil were snared out of the patient.The coil was in place in the target lesion, but part of the filament extended down into the aorta.There was no further intervention reported, and 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: 22668560
• Report Number: 2124215-2025-51770
• Device Sequence Number: 3824795
• Product Code: KRD
• UDI-Device Identifier: 08714729983552
• UDI-Public: (01)08714729983552
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: M001394240030120
• Device Catalogue Number: M001394240030120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other; Required Intervention
• Patient Sex: Unknown