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

Model Number	M001394240030060
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: the event date was approximated to 12/02/2024 based on the date that boston scientific became aware of the event.E1 - initial reporter phone number: (b)(6).Device analysis: the device was examined microscopically and revealed the couplers were bent with the coil separated from the coupler.The coupler deployed successfully during a functional test.The coil was severely stretched from approximately 1cm from the distal tip.The product analysis could not confirm the reported failure to advance through a microcatheter.
Event or Problem Description
Reportable based off device analysis completed on 23jan2025.An embold fibered 3x6 was selected for use.During advancement, it was reported that the coil was unable to advance through the microcatheter.The coil was irrigated, removed, and advancement was attempted once again, but was unsuccessful.The device was removed from the patient and another coil was used to complete the procedure.There were no reported patient complications.However, device analysis revealed the coupler was detached.

• 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: 21414492
• Report Number: 2124215-2025-08299
• Device Sequence Number: 8523406
• Product Code: KRD
• UDI-Device Identifier: 08714729983545
• UDI-Public: 08714729983545
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: M001394240030060
• Device Catalogue Number: M001394240030060
• Device Lot Number: 0033842596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown