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

Model Number	M001394240030120
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 3x12 embold fibered embolic device was returned with the perforations intact, wedge lock removed, with the delivery wire in the delivery sheath.The device was examined visually and microscopically to reveal the coil was detached from the coupler and stretched in the delivery sheath.Both couplers were bent and remained connected by the pull wire.The damage would have contributed to the resistance felt by the user, preventing the device from advancing.
Event or Problem Description
Reportable based on analysis completed on 04apr2025.The returned device evaluation revealed the coil was detached from the coupler.It was reported that the device was difficult to advance.This 3x12 embold fibered embolic device was selected for use during a renal artery embolization procedure.During the procedure, the physician selected the renal artery with a renegade stc 130 cm with minimal difficulty.It was noted there was some tortuous anatomy.They flushed the renegade stc prior to advancing this embold coil, then loaded and advanced the coil in normal fashion.Resistance was met when the coil approached the distal end of the renegade stc.They attempted to form the coil in the vessel and met resistance again.They opted to recapture the coil, and try a smaller and shorter embold coil, which advanced and deployed in the patient without difficulty.There were no patient complications as a result of the 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: 21922907
• Report Number: 2124215-2025-21589
• Device Sequence Number: 8795504
• Product Code: KRD
• UDI-Device Identifier: 08714729983552
• UDI-Public: (01)08714729983552(17)261025(10)32725957
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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: 0032725957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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 Age: 71 YR
• Patient Sex: Male