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

Model Number	83910
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Malposition of Device (2616); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was malpositioned, requiring snaring, and vessel spasm occurred, requiring medications.This 2x4 embold fibered detachable coil system was selected for use in a phrenic artery embolization procedure.It was noted that the vessel was moderately tortuous.During the procedure, the coil was advanced through a 2f truselect microcatheter into a sub-2mm phrenic artery branch.After being advanced approximately 2 cm into the microcatheter, significant resistance was felt, and it was difficult to advance the coil.Additionally, vessel spasm was observed at that time.The patient received nitroglycerin in order to improve the vessel spasm.An attempt was made to push and retract the coil several times, and when attempting to resheath the coil, the coil would not retract into the sheath.The microcatheter was removed; however, the coil remained in the phrenic artery branch and was noted to have stretched.A snare was then used to remove the coil.The procedure was completed with a different embold device and there were no patient complications.
Event or Problem Description
It was reported that the coil was malpositioned, requiring snaring, and vessel spasm occurred, requiring medications.This 2x4 embold fibered detachable coil system was selected for use in a phrenic artery embolization procedure.It was noted that the vessel was moderately tortuous.During the procedure, the coil was advanced through a 2f truselect microcatheter into a sub-2mm phrenic artery branch.After being advanced approximately 2 cm into the microcatheter, significant resistance was felt, and it was difficult to advance the coil.Additionally, vessel spasm was observed at that time.The patient received nitroglycerin in order to improve the vessel spasm.An attempt was made to push and retract the coil several times, and when attempting to resheath the coil, the coil would not retract into the sheath.The microcatheter was removed; however, the coil remained in the phrenic artery branch and was noted to have stretched.A snare was then used to remove the coil.The procedure was completed with a different embold device and there were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory this embold fibered coil system was visually and microscopically examined.Visual examination revealed a stretched and separated partial coil with bent couplers.The delivery wire/proximal tip was received inside the delivery sheath.The perforations were snapped from the customer site but not pulled.Microscopic examination revealed a stretched coil and separated partial coil with bent couplers.The coil was detached from the distal coupler weld.The complaint was confirmed for issues due to coil and delivery wire damage.

• 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: 20622745
• Report Number: 2124215-2024-67882
• Device Sequence Number: 18369132
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/03/2024

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: 0034038261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: Male