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

Model Number	M001394240320600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event and patient status, but further information was unable to be obtained.
Event or Problem Description
It was reported that the coil broke, and there were unretrievable device fragments requiring additional intervention.A 32mm x 60cm embold fibered coil was selected for use in a 3cm splenic aneurysm embolization procedure.The vessel was moderately tortuous.During the procedure, intermittent flushing was performed, and the coil was advanced through a 2.8f non-boston scientific catheter.While attempting to get the coil to form, the coil kept flying down the outflow vessel.Three attempts to reposition the coil were made when it was observed that the coil was not responding to the physician's movements.Resistance was felt.Snaring was attempted on the proximal end for over an hour unsuccessfully.The coil stretched and was unable to come out; the coil broke and kept fragmenting during retrieval attempts.The coil was partially explanted, but a portion remains implanted.The procedure was prolonged, and additional surgery was required.
Additional Manufacturer Narrative
Device eval by manufacturer: the embold fibered coil was returned for analysis.The device was examined visually and microscopically to reveal a stretched coil and a broken coupler.Inspection of the remainder of the device presented no other damage or irregularities.Good faith effort attempts were made to try and retrieve additional details regarding the reported event and patient status, but further information was unable to be obtained.
Event or Problem Description
It was reported that the coil broke, and there were unretrieved device fragments requiring additional intervention.A 32mm x 60cm embold fibered coil was selected for use in a 3cm splenic aneurysm embolization procedure.The vessel was moderately tortuous.During the procedure, intermittent flushing was performed, and the coil was advanced through a 2.8f non-boston scientific catheter.While attempting to get the coil to form, the coil kept flying down the outflow vessel.Three attempts to reposition the coil were made when it was observed that the coil was not responding to the physician's movements.Resistance was felt.Snaring was attempted on the proximal end for over an hour unsuccessfully.The coil stretched and was unable to come out; the coil broke and kept fragmenting during retrieval attempts.The coil was partially explanted, but a portion remains implanted.The procedure was prolonged, and additional surgery was required.It was further reported that this was the first coil to be placed in the round aneurysm.The portion of the coil that was unable to be retrieved after multiple attempts was left in the non-target distal splenic artery and aorta.A vascular surgery consult was planned, but it remains unknown if this surgery occurred or not.The patient also had to be brought back to embolize the aneurysm that was unsuccessfully treated with embold.
Additional Manufacturer Narrative
Device eval by manufacturer: the embold fibered coil was returned for analysis.The device was examined visually and microscopically to reveal a stretched coil and a broken coupler.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the coil broke, and there were unretrieved device fragments requiring additional intervention.A 32mm x 60cm embold fibered coil was selected for use in a 3cm splenic aneurysm embolization procedure.The vessel was moderately tortuous.During the procedure, intermittent flushing was performed, and the coil was advanced through a 2.8f non-boston scientific catheter.While attempting to get the coil to form, the coil kept flying down the outflow vessel.Three attempts to reposition the coil were made when it was observed that the coil was not responding to the physician's movements.Resistance was felt.Snaring was attempted on the proximal end for over an hour unsuccessfully.The coil stretched and was unable to come out; the coil broke and kept fragmenting during retrieval attempts.The coil was partially explanted, but a portion remains implanted.The procedure was prolonged, and additional surgery was required.It was further reported that this was the first coil to be placed in the round aneurysm.The portion of the coil that was unable to be retrieved after multiple attempts was left in the non-target distal splenic artery and aorta.A vascular surgery consult was planned, but it remains unknown if this surgery occurred or not.The patient also had to be brought back to embolize the aneurysm that was unsuccessfully treated with embold.It was further reported that the base catheter was in the proximal splenic artery with the microcatheter placed coaxially.Before this 32mm x 60cm embold fibered coil was selected for use, 2-3 other embold coils were attempted to be deployed distal to the aneurysm; however, due to hyperdynamic flow, they were removed as they would not anchor in the outflow portion of the splenic artery.This 32 mm x 60 mm embold fibered coil was advanced into the aneurysm sac however preferentially flowed into the outflow artery.During numerous attempts to reposition, the physician did not realize that the coil was stretched, and coil detachment resulted in extension of the coil from the splenic artery into the abdominal aorta.Numerous attempts in retrieving the coil with a snare were unsuccessful.A vascular consult was called with no planned surgical intervention to remove the coil.The coil was left in place, and the patient was placed on aspirin.The patient underwent a subsequent procedure where successful coil embolization of the aneurysm was performed.There were no clinically identified complications.

• 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: 22952722
• Report Number: 2124215-2025-61409
• Device Sequence Number: 15518824
• Product Code: KRD
• UDI-Device Identifier: 00191506010485
• UDI-Public: (01)00191506010485(17)280521(10)36584916
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: M001394240320600
• Device Catalogue Number: M001394240320600
• Device Lot Number: 0036584916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 10/22/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/07/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White