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

Model Number	M001394240020060
Medical Device Problem Codes	Malposition of Device (2616); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil deployed in an unintended location.A 2mm x 6cm embold fibered coil was selected for use in an esophageal artery embolization procedure.The coil was advanced through a truselect microcatheter.Upon breaking the proximal release perforation and pulling back, the coil did not deploy.The system was pulled back, and the coil detached in an unintended location.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to obtain the lot number, but it was unknown by the account/customer.
Event or Problem Description
It was reported that the coil deployed in an unintended location.A 2mm x 6cm embold fibered coil was selected for use in an esophageal artery embolization procedure.The coil was advanced through a truselect microcatheter.Upon breaking the proximal release perforation and pulling back, the coil did not deploy.The system was pulled back, and the coil detached in an unintended location.No patient complications were reported.It was further reported the target vessel size was 2mm and located in severely tortuous anatomy.The coil deployed in the left hepatic artery.No actions taken or planned to correct the coil's placement.

• 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: 21304743
• Report Number: 2124215-2025-05739
• Device Sequence Number: 8848595
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: M001394240020060
• Device Catalogue Number: M001394240020060
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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
• Patient Sex: Unknown