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

Model Number	M001394240080200
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was protruding from the target location.An 8mm x 20cm embold fibered coil was selected for use in an embolization procedure to treat a type ib endoleak of an abdominal aortic aneurysm (aaa).The embolization area was between the aortic wall and the stent graft.The anatomy was mildly tortuous.During the procedure, the aaa sac was packed with coils.Prior to this coil, a number of non-boston scientific coils had been deployed.The embold fibered coil was advanced as expected through a 1.5f non-boston scientific catheter.However, when almost ready to deploy the coil, the user felt something break.They were under the impression that the coil had prematurely deployed, so the delivery wire was removed.The technician reported intentionally breaking the deployment mechanism but could not recall at exactly what moment it was broken.The coil remained in place, and it was thought that all was well.However, at close, a very thin coil-like string was coming out of the groin.The coil had stretched all the way to the groin.Scissors were used to cut what was outside the body, and the rest was left implanted.The coil was left protruding from the target location into the iliac artery.No attempt was made to snare the coil.There is no planned intervention to correct the coil's position or remove it.The procedure was completed with this device.No patient complications were reported.The patient was doing just fine.
Event or Problem Description
It was reported that the coil was protruding from the target location.An 8mm x 20cm embold fibered coil was selected for use in an embolization procedure to treat a type ib endoleak of an abdominal aortic aneurysm (aaa).The embolization area was between the aortic wall and the stent graft.The anatomy was mildly tortuous.During the procedure, the aaa sac was packed with coils.Prior to this coil, a number of non-boston scientific coils had been deployed.The embold fibered coil was advanced as expected through a 1.5f non-boston scientific catheter.However, when almost ready to deploy the coil, the user felt something break.They were under the impression that the coil had prematurely deployed, so the delivery wire was removed.The technician reported intentionally breaking the deployment mechanism but could not recall at exactly what moment it was broken.The coil remained in place, and it was thought that all was well.However, at close, a very thin coil-like string was coming out of the groin.The coil had stretched all the way to the groin.Scissors were used to cut what was outside the body, and the rest was left implanted.The coil was left protruding from the target location into the iliac artery.No attempt was made to snare the coil.There is no planned intervention to correct the coil's position or remove it.The procedure was completed with this device.No patient complications were reported.The patient was doing just fine.

• 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: 21276995
• Report Number: 2124215-2025-03734
• Device Sequence Number: 3601401
• Product Code: KRD
• UDI-Device Identifier: 08714729983620
• UDI-Public: 08714729983620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 02/26/2025

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: M001394240080200
• Device Catalogue Number: M001394240080200
• Device Lot Number: 0034095278
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 05/23/2024
• 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
• Patient Sex: Unknown