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

Model Number	M001394240020060
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke and stretched outside the target location.A 2mm x 6cm embold fibered coil was selected for use in an intercostal artery embolization procedure.During the procedure, the coil and couplers were advanced outside the microcatheter tip with some resistance, but even after breaking the proximal release perforation and pulling the pull wire, the coil did not release.Therefore, the coil was pulled, and unraveling occurred.The coil eventually broke at the link part and was placed inside the body.The desired intercostal artery was embolized, but part of the proximal side of the coil was unraveled and hanging down into the aorta.The proximal side of the device from the link part was removed from the body.The procedure was completed using this device.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: 22020185
• Report Number: 2124215-2025-30298
• Device Sequence Number: 15657139
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: (01)08714729983538(17)280227(10)35951091
• 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): 05/14/2025

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: M001394240020060
• Device Catalogue Number: M001394240020060
• Device Lot Number: 0035951091
• 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: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 02/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREAKTHROUGH 2MARKER MICROCATHETER
• Patient Sex: Unknown