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

Model Number	M001394240320600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the device was not returned for analysis; however, the customer provided media.The media was examined and evaluated to reveal x-ray imaging of the coil tangled in the patient's vessel.Additionally, a photo of the coil retrieved from the patient showed that the coil was tangled and stretched.Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot# is unknown at this time, we are unable to provide the complete unique identifier (udi)# and other product specific information.However, a ship history for the reported upn was performed for the reporting customer.Three batches (36295245, 30876594, and 30262914) had shipped to the reporting facility during the reporting period.
Event or Problem Description
It was reported that the device broke.A 32mm x 60cm embold fibered coil was selected for use in variceal embolization following a transjugular intrahepatic portosystemic shunt (tips) procedure.The non-tortuous vessel was accessed using a non-boston scientific microcatheter.The physician attempted to place the coil in a large varicose; however, the coil did not anchor, so multiple attempts to reposition were made.The coil release mechanism was never activated.When attempting to remove the coil, it appeared to knot resulting in stretching and the delivery wire becoming detached.The physician was able to fully remove everything by pulling the stretched coil.The procedure was completed with idc 35 coils.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: 22572327
• Report Number: 2124215-2025-49308
• Device Sequence Number: 13207698
• Product Code: KRD
• UDI-Device Identifier: 00191506010485
• UDI-Public: (01)00191506010485
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/22/2025

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: M001394240320600
• Device Catalogue Number: M001394240320600
• 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: 06/23/2025
• Initial Report FDA Received Date: 07/22/2025
• 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
• Patient Sex: Unknown