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

Model Number	M001394240050150
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke.A 5mm x 15cm embold fibered coil was selected for use in the embolization of a gastrointestinal bleed with splenic takedown.The vessel was severely tortuous.Intermittent flushing was performed during the procedure.When advancing the coil out of the 2.8f non-boston scientific microcatheter, the physician wasn't able to keep pushing and advancing the coil.An attempt was made to pull the coil back in and then re-advance, but this did not help.Eventually, the physician went to pull back and remove the coil, but there was resistance, and it stretched upon removal.The release mechanism was never used.It was believed that all of the coil was removed because the microcatheter was able to be flushed with saline and contrast.However, when obsidio was injected in the microcatheter, it pushed a remaining section of stretched coil out into the vessel together with the obsidio material.The coil fragment was implanted somewhat proximal but around where they wanted to embolize.Due to catheter kickback experienced during obsidio use, the microcatheter was pulled into the base catheter, and the procedure was considered complete.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the coil broke.A 5mm x 15cm embold fibered coil was selected for use in the embolization of a gastrointestinal bleed with splenic takedown.The vessel was severely tortuous.Intermittent flushing was performed during the procedure.When advancing the coil out of the 2.8f non-boston scientific microcatheter, the physician wasn't able to keep pushing and advancing the coil.An attempt was made to pull the coil back in and then re-advance, but this did not help.Eventually, the physician went to pull back and remove the coil, but there was resistance, and it stretched upon removal.The release mechanism was never used.It was believed that all of the coil was removed because the microcatheter was able to be flushed with saline and contrast.However, when obsidio was injected in the microcatheter, it pushed a remaining section of stretched coil out into the vessel together with the obsidio material.The coil fragment was implanted somewhat proximal but around where they wanted to embolize.Due to catheter kickback experienced during obsidio use, the microcatheter was pulled into the base catheter, and the procedure was considered complete.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: 22635492
• Report Number: 2124215-2025-50644
• Device Sequence Number: 18181385
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: (01)08714729983590(17)280227(10)35951144
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/08/2025

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: 0035951144
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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: 2.8F PROGREAT MICROCATHETER; 2.8F PROGREAT MICROCATHETER
• Patient Sex: Unknown