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); Difficult to Remove (1528); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was resistance when attempting to remove the embold coil, which resulted in the coil deploying inadvertently and unintentionally embolizing the collateral vessel.An embold fibered 18x50 was selected for use during the endoleak procedure.The physician used two embold fibered 14x50 coils to fill the endoleak through a collateral vessel, and then proceeded to advance the embold 18x50 through a 130cm truselect microcatheter.The 18x50 was slightly too large, so the physician attempted to retract the coil and remove it from the patient.As the entire system was attempted to be removed, the coil met resistance and detached from the pusher wire, inadvertently deploying.The coil was halfway into the target location, but the remainder of the coil was in the collateral vessel.There was no possibility of snaring out the coil.As a result of the inadvertent deployment, the collateral vessel was unintentionally embolized.Multiple images were ordered to ensure that the collateral vessel was not needed to supply adequate blood flow to all neighboring organs.Imaging revealed the collateral vessel was not needed.The physician established that the coil had no potential of migration.After the delivery system was removed, the device was manipulated to ensure no other parts of the pusher wire or inner core wire had unintentionally deployed within the patient.There were no further reported consequences to the patient.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16308664
• Report Number: 2124215-2023-04128
• Device Sequence Number: 6792024
• Product Code: KRD
• UDI-Device Identifier: 08714729983729
• UDI-Public: 08714729983729
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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 Expiration Date: 08/09/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029927953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: TRUSELECT 130 CM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male