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

Model Number	M001394240030120
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the previously implanted coil was removed unintentionally by another coil, and the coil broke.A 3mm x 12cm embold fibered coil was selected for use in the embolization of an internal iliac artery aneurysm.After placing one 3mm x 12cm embold fibered coil, an attempt was made to place another 3mm x 12cm embold fibered coil.Intermittent flushing was performed throughout this procedure, but flushing was not performed before inserting the coil.There was difficulty inserting the device.The coil made it to the distal part of the 0.027-inch non-boston scientific microcatheter, but there was resistance, so it was suspected that the coil had unraveled.When the coil was pulled back into the microcatheter, the previously placed coil was also pulled into the microcatheter.The entire microcatheter was removed from the body, and when the coil was removed to try to investigate the event, it was discovered that one of the two coils was missing.It did not remain inside the body, and it did not fall into the surgical field.It was possibly still inside the microcatheter.The coil that was found appeared separated without being unraveled.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2: age at time of event: the patient is over 18 years old.
Event or Problem Description
It was reported that the previously implanted coil was removed unintentionally by another coil, and the coil broke.A 3mm x 12cm embold fibered coil was selected for use in the embolization of an internal iliac artery aneurysm.After placing one 3mm x 12cm embold fibered coil, an attempt was made to place another 3mm x 12cm embold fibered coil.Intermittent flushing was performed throughout this procedure, but flushing was not performed before inserting the coil.There was difficulty inserting the device.The coil made it to the distal part of the 0.027-inch non-boston scientific microcatheter, but there was resistance, so it was suspected that the coil had unraveled.When the coil was pulled back into the microcatheter, the previously placed coil was also pulled into the microcatheter.The entire microcatheter was removed from the body, and when the coil was removed to try to investigate the event, it was discovered that one of the two coils was missing.It did not remain inside the body, and it did not fall into the surgical field.It was possibly still inside the microcatheter.The coil that was found appeared separated without being unraveled.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the previously implanted coil was removed unintentionally by another coil, and the coil broke.A 3mm x 12cm embold fibered coil was selected for use in the embolization of an internal iliac artery aneurysm.After placing one 3mm x 12cm embold fibered coil, an attempt was made to place another 3mm x 12cm embold fibered coil.Intermittent flushing was performed throughout this procedure, but flushing was not performed before inserting the coil.There was difficulty inserting the device.The coil made it to the distal part of the 0.027-inch non-boston scientific microcatheter, but there was resistance, so it was suspected that the coil had unraveled.When the coil was pulled back into the microcatheter, the previously placed coil was also pulled into the microcatheter.The entire microcatheter was removed from the body, and when the coil was removed to try to investigate the event, it was discovered that one of the two coils was missing.It did not remain inside the body, and it did not fall into the surgical field.It was possibly still inside the microcatheter.The coil that was found appeared separated without being unraveled.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: 22766648
• Report Number: 2124215-2025-55200
• Device Sequence Number: 15632681
• Product Code: KRD
• UDI-Device Identifier: 08714729983552
• UDI-Public: (01)08714729983552(17)280501(10)36426108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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: M001394240030120
• Device Catalogue Number: M001394240030120
• Device Lot Number: 0036426108
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 10/08/2025
• Initial Report FDA Received Date: 08/09/2025
• Supplement Report FDA Received Date: 09/09/2025; 11/05/2025
• Date Device Manufactured: 05/02/2025
• 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
• Patient Sex: Unknown