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

Model Number	M001394240050150
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 27may2025.It was reported that a 5mm x 15cm embold fibered coil was selected for use in the embolization of a common hepatic artery aneurysm.During the procedure, the microcatheter reached the lesion smoothly with a gentle curve.After connecting the embold device to the microcatheter, the inner sheath of the embold was pushed out, but it was very stiff from the start and did not slide through the outer sheath.Intermittent flushing was performed.The coil could not be inserted into the microcatheter.The coil did not exit the introducer sheath and was removed as it was.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a coil break from the coupler.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of an embold fibered coil system with the perforations intact.Visual and microscopic examination revealed a coil break from the coupler and a stretched coil.

• 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: 22310512
• Report Number: 2124215-2025-41270
• Device Sequence Number: 8082301
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: (01)08714729983590(17)271126(10)35366360
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: M001394240050150
• Device Catalogue Number: M001394240050150
• Device Lot Number: 0035366360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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