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

Model Number	83910
Medical Device Problem Codes	Break (1069); Malposition of Device (2616); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil malpositioned.A 2x6 embold fibered detachable coil system was selected for use in pre-y-90 embolization.During the procedure, the coil was placed, and the perforation was snapped as normal deployment goes; however, the coil did not deploy.Upon further pulling of the pull wire, the pull wire broke.Kelly forceps were used to grab the wire with the coil still connected.When removed, it moved the coil.The coil mispositioned and could not be repositioned.The procedure was completed.No patient complications were reported, and the patient fully recovered.It was further reported that this coil was intended to be placed in the vessels leading to the liver.After the pull wire broke, the coil eventually deployed, but when the delivery wire was pulled, it moved the coil from its intended position.
Event or Problem Description
It was reported that the coil malpositioned.A 2x6 embold fibered detachable coil system was selected for use in pre-y-90 embolization.During the procedure, the coil was placed, and the perforation was snapped as normal deployment goes; however, the coil did not deploy.Upon further pulling of the pull wire, the pull wire broke.Kelly forceps were used to grab the wire with the coil still connected.When removed, it moved the coil.The coil mispositioned and could not be repositioned.The procedure was completed.No patient complications were reported, and the patient fully recovered.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• 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: 19514966
• Report Number: 2124215-2024-35287
• Device Sequence Number: 7326706
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/03/2024

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: 83910
• Device Catalogue Number: 83910
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown