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

Model Number	M001394240040150
Medical Device Problem Codes	Break (1069); Stretched (1601); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device lot number 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 product lot number is unknown, we are unable to provide the complete unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that the coil broke requiring additional intervention to remove portions of the coil.A 4mm x 15cm embold fibered coil was selected for use in a coil embolization procedure to treat a bleed in a 3mm moderately tortuous splenic artery.The physician did not like the way the coil was forming in the vessel and went to bring it back into the microcatheter.A "pop" was felt and the coil broke while inside the catheter.The physician assumed the coil deployed.It was then determined that the coil stretched from the hepatic artery to the aorta.Some portions of the stretched coil were removed using a snare and some portions remained inside the patient.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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21961895
• Report Number: 2124215-2025-28169
• Device Sequence Number: 7272876
• Product Code: KRD
• UDI-Device Identifier: 08714729983576
• UDI-Public: (01)08714729983576
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001394240040150
• Device Catalogue Number: M001394240040150
• 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: 04/08/2025
• Initial Report FDA Received Date: 05/05/2025
• 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: CATHETER: PROGREAT 2.4.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown