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

Model Number	M001394240050150
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: mfr site zip/post code: (b)(6).Investigation results: device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis: the returned device consists of an embold fibered delivery system with the perforations intact.Visual examination revealed a stretched coil in the delivery sheath.Microscopic examination revealed a coil detached from the distal coupler while the coupler remains attached to the proximal coupler.The proximal coupler is bent.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as failure to follow instructions.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the coil prematurely detached in the catheter.A 5x15 embold fibered was selected for use in an inferior mesenteric artery embolization procedure.The target location was moderately tortuous and moderately calcified.During the procedure, the coil detached early inside the middle part of the non-boston scientific catheter.The inner diameter of the catheter was 0.022 inches.The entire catheter was removed from the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a coil detached from the distal coupler while the coupler remains attached to the proximal coupler.

• 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25017802
• Report Number: 2124215-2026-22814
• Device Sequence Number: 18515819
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: (01)08714729983590(17)280925(10)37554380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: M001394240050150
• Device Catalogue Number: M001394240050150
• Device Lot Number: 0037554380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: BREAKTHROUGH 2RO.
• Patient Sex: Unknown