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

Model Number	M001394240020040
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this embold fibered coil was returned with the coil missing.Upon further inspection, the coil was detached from the distal coupler.The perforations were still intact, and the couplers were not separated.The advancement of the device was unable to be tested, as the coil was not returned.No other visual or functional abnormalities were noted.The reported event of coil separation was confirmed.
Event or Problem Description
It was reported that the device may have fractured.This 2x4 embold fibered device was selected for use during a kidney biopsy procedure.During the procedure, the coil became stuck in the middle part of the catheter.The coil was removed along with the catheter, and the procedure was completed with a different device.There was no patient injury.It was additionally noted that there was a possibility that it fractured at the locking section.It was also reported as it may have torn off at the locking part at the middle of the catheter.

• 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: 21537365
• Report Number: 2124215-2025-13753
• Device Sequence Number: 8050865
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: M001394240020040
• Device Catalogue Number: M001394240020040
• Device Lot Number: 0034021073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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