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); Premature Activation (1484); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an unretrieved device left in the patient following an unsuccessful snare attempt.An embold fibered 6x20 was selected for use in the embolization procedure to treat a gastroduodenal artery (gda) aneurysm.The target vessel was reported to be tortuous.When the coil was attempted to be reconstrained in the microcatheter for better placement, there was resistance encountered, and the coil appeared to stretch.The physician continued to retract the delivery wire, at which point several snapping sensations were felt, and the coil detached at the polymer shaft, distal to the proximal coupler.The delivery wire was withdrawn from the microcatheter, and a snare was used to attempt to retrieve the coil.The coil was unable to be retrieved, and the stretched coil ultimately remained in the patient.The procedure was completed.There were no reported patient complications as a result of the unretrieved device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17137881
• Report Number: 2124215-2023-30653
• Device Sequence Number: 17587873
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: 08714729983613
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/15/2023

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: 02/01/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030976309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown