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

Model Number	83910
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil premature deployed in a non-target vessel and was attempted to be removed.This 2x6 embold fibered detachable coil system was selected for use in a renal embolization procedure.During the procedure, the coil prematurely deployed in the patient's vasculature and was not placed correctly in the target location.Numerous attempts were made to remove the coil without success.An additional coil was needed to complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that the coil premature deployed in a non-target vessel and was attempted to be removed.This 2x6 embold fibered detachable coil system was selected for use in a renal embolization procedure.During the procedure, the coil prematurely deployed in the patient's vasculature and was not placed correctly in the target location.Numerous attempts were made to remove the coil without success.An additional coil was needed to complete the procedure.There were no patient complications.It was further reported that the renal vessel was successfully embolized.The additional coil was implanted to complete the embolization.The first coil which prematurely deployed was also in the renal vessel, but not in the intended location.

• 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: 19598793
• Report Number: 2124215-2024-35507
• Device Sequence Number: 3970169
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/01/2024

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: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0033719488
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/01/2024
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown