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

Model Number	M001394240020060
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke.A 2mm x 6cm embold? fibered coil was selected for use in an embolization procedure to treat a renal bleed.During the procedure, the coil and microcatheter prolapsed out of the target vessel.During attempted removal of the coil, it detached and unraveled within the microcatheter.It was difficult to remove the unraveled fibers, and not all of the pieces were able to be removed.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event and patient outcome, but further information was unable to be obtained.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of an incomplete embold fibered coil.The device was examined visually and microscopically to reveal that the coil was separated at the couplers, and the couplers were bent.The coil was not received with the device.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 outcome, but further information was unable to be obtained.
Event or Problem Description
It was reported that the device broke.A 2mm x 6cm embold? fibered coil was selected for use in an embolization procedure to treat a renal bleed.During the procedure, the coil and microcatheter prolapsed out of the target vessel.During attempted removal of the coil, it detached and unraveled within the microcatheter.It was difficult to remove the unraveled fibers, and not all of the pieces were able to be removed.It was further reported that the attempted embolization was of a small cortical branch artery.The procedure was prolonged due to attempts to remove the unraveled coil.Ultimately a long portion of it was removed; however, a small, unraveled fiber was unable to be removed.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of an incomplete embold fibered coil.The device was examined visually and microscopically to reveal that the coil was separated at the couplers, and the couplers were bent.The coil was not received with the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the device broke.A 2mm x 6cm embold? fibered coil was selected for use in an embolization procedure to treat a renal bleed.During the procedure, the coil and microcatheter prolapsed out of the target vessel.During attempted removal of the coil, it detached and unraveled within the microcatheter.It was difficult to remove the unraveled fibers, and not all of the pieces were able to be removed.It was further reported that the attempted embolization was of a small cortical branch artery.The procedure was prolonged due to attempts to remove the unraveled coil.Ultimately a long portion of it was removed; however, a small, unraveled fiber was unable to be removed.It was further reported that the indication of this procedure was a post ablation renal hemorrhage.The physician identified a bleed coming from a sub-1.0 mm distal renal artery.The vessel was mildly tortuous, and intermittent flushing was performed.The base catheter was in the main renal artery with microcatheter placed coaxially.There was difficulty/resistance pushing the coil out of the microcatheter.The coil would not form and was completely straight in the renal artery.The physician tried to push forward on both the coil and the microcatheter with great difficulty.It was determined that the coil was oversized in both diameter and length.With the forward pressure in attempts to advance, the microcatheter and base catheter kicked out into the abdominal aorta.With the difficult angles, access was unable to be re-established.Resistance was felt while retracting the coil, and the coil stretched.The coil was now extending from the distal renal artery into the abdominal aorta.Attempts were made to snare/retrieve the coil.Segments were retrieved.The decision was made to leave the residual portions of the coil in place.The patient was maintained on aspirin.There were no clinically identified complications.The procedure was completed with a non-boston scientific coil and was successful in shutting down the renal bleed.The patient's outcome was a successful embolization.

• 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: 22904553
• Report Number: 2124215-2025-60024
• Device Sequence Number: 18120410
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: (01)08714729983538(17)280312(10)36059604
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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: M001394240020060
• Device Catalogue Number: M001394240020060
• Device Lot Number: 0036059604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 10/17/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/02/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White