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

Model Number	83910
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was protruding from the target location.An embold fibered 10x50 detachable coil system was selected for use in the embolization procedure.The coil was intended to be deployed distally in the varicocele vein.The physician advanced the coil to the target location of deployment and ensured that the couplers were outside of the microcatheter before breaking the proximal release perforation to deploy the coil, but the coil did not detach.The physician retracted the pull wire further, but the coil still did not deploy.The microcatheter was pulled back and an alternate pusher wire was utilized to push the coil into the target location.Due to the additional manipulation, the proximal tip of the coil was deployed more proximally in the vessel than intended.The proximal portion of the coil protruded from the target lesion.No further action was taken as a result of the unintended coil placement.The procedure was successfully completed and there were no reported patient complications.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17504645
• Report Number: 2124215-2023-41371
• Device Sequence Number: 14977786
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: 08714729983651
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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 Expiration Date: 05/14/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031616598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown