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

Model Number	M001394240030120
Medical Device Problem Codes	Break (1069); Stretched (1601); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-deployment, the coil became stuck to the tip of the microcatheter, and additional intervention was required.A 3mm x 12cm embold fibered coil was selected for use in the embolization of an abdominal aortic aneurysm in the mildly tortuous median sacral artery.Intermittent flushing was performed.The coil was advanced through a 0.027inch non-boston scientific microcatheter.After deploying this coil, when the delivery wire was pulled, it was found that the distal coupler of the coil was connected to the tip of the microcatheter.When the microcatheter was pulled, the coil was still connected.While attempting to remove the microcatheter together with the coil, the microcatheter and coil became separated inside the body.While attempting to retrieve the coil with a snare, the coil unraveled/broke.The coil was observed to be stretched and broken in two pieces.The part of the coil that was grasped with the snare was able to be retrieved, but the other half of the unraveled coil could not be retrieved and remained in the non-target internal iliac artery.The procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that post-deployment, the coil became stuck to the tip of the microcatheter, and additional intervention was required.A 3mm x 12cm embold fibered coil was selected for use in the embolization of an abdominal aortic aneurysm in the mildly tortuous median sacral artery.Intermittent flushing was performed.The coil was advanced through a 0.027inch non-boston scientific microcatheter.After deploying this coil, when the delivery wire was pulled, it was found that the distal coupler of the coil was connected to the tip of the microcatheter.When the microcatheter was pulled, the coil was still connected.While attempting to remove the microcatheter together with the coil, the microcatheter and coil became separated inside the body.While attempting to retrieve the coil with a snare, the coil unraveled/broke.The coil was observed to be stretched and broken in two pieces.The part of the coil that was grasped with the snare was able to be retrieved, but the other half of the unraveled coil could not be retrieved and remained in the non-target internal iliac artery.The procedure was completed.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: 21741336
• Report Number: 2124215-2025-19671
• Device Sequence Number: 4007379
• Product Code: KRD
• UDI-Device Identifier: 08714729983552
• UDI-Public: (01)08714729983552(17)270925(10)34925364
• 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,Followup
• Report Date (Section B): 04/28/2025

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: M001394240030120
• Device Catalogue Number: M001394240030120
• Device Lot Number: 0034925364
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 09/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEONIS MOVA MICROCATHETER.; LEONIS MOVA MICROCATHETER.
• Patient Sex: Unknown