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

Model Number	M001394240050080
Medical Device Problem Codes	Break (1069); Stretched (1601); Malposition of Device (2616); Difficult to Advance (2920); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deployment issues occurred, the coil was snared, and the coil broke.A 5mm x 8cm embold fibered coil was selected for use in a right renal mass embolization procedure.Several 4mm x 8cm coils and one 5mm x 8cm coil were placed.While attempting to place the last coil (this 5mm x 8cm embold fibered coil), it was difficult to get the last bit of the coil into the vessel.Once they did, upon deploying the coil, the coil wanted to come back into the microcatheter and failed to detach.While attempting to slowly recapture the coil in order to remove it, the coil deployed but was no longer where it needed to be; the coil was in the main renal artery.To avoid embolizing the entire right kidney, the coil was snared but broke into two pieces when pulling it out.Both pieces were retrieved.The catheter, snare, and coil were removed all together.Imaging was able to confirm that the coil was fully removed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that deployment issues occurred, the coil was snared, and the coil broke.A 5mm x 8cm embold fibered coil was selected for use in a right renal mass embolization procedure.Several 4mm x 8cm coils and one 5mm x 8cm coil were placed.While attempting to place the last coil (this 5mm x 8cm embold fibered coil), it was difficult to get the last bit of the coil into the vessel.Once they did, upon deploying the coil, the coil wanted to come back into the microcatheter and failed to detach.While attempting to slowly recapture the coil in order to remove it, the coil deployed but was no longer where it needed to be; the coil was in the main renal artery.To avoid embolizing the entire right kidney, the coil was snared but broke into two pieces when pulling it out.Both pieces were retrieved.The catheter, snare, and coil were removed all together.Imaging was able to confirm that the coil was fully removed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that deployment issues occurred, the coil was snared, and the coil broke.A 5mm x 8cm embold fibered coil was selected for use in a right renal mass embolization procedure.Several 4mm x 8cm coils and one 5mm x 8cm coil were placed.While attempting to place the last coil (this 5mm x 8cm embold fibered coil), it was difficult to get the last bit of the coil into the vessel.Once they did, upon deploying the coil, the coil wanted to come back into the microcatheter and failed to detach.While attempting to slowly recapture the coil in order to remove it, the coil deployed but was no longer where it needed to be; the coil was in the main renal artery.To avoid embolizing the entire right kidney, the coil was snared but broke into two pieces when pulling it out.Both pieces were retrieved.The catheter, snare, and coil were removed all together.Imaging was able to confirm that the coil was fully removed.There were no patient complications as a result of this event.It was further reported that the coil looked good when placed but they had to pack it a little bit to get the last bit of the coil in the target area.The delivery wire felt good when pushing the coil, but when attempting to release, it wouldn't come off.The coil didn't stretch until they used a snare to recover it.

• 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: 22175791
• Report Number: 2124215-2025-37582
• Device Sequence Number: 18092527
• Product Code: KRD
• UDI-Device Identifier: 08714729983583
• UDI-Public: (01)08714729983583(17)270104(10)33150576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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: M001394240050080
• Device Catalogue Number: M001394240050080
• Device Lot Number: 0033150576
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 07/07/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/04/2025
• Date Device Manufactured: 01/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White