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); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Media analysis: the device was not returned for analysis; however, fluoroscopic images were provided.The reported event was unable to be confirmed by the media provided by the site, as the fluoroscopic media did not clearly depict a failure of the device.
Event or Problem Description
It was reported that there were unretrieved device fragments.A 14x30 embold fibered detachable coil system was selected for use in the embolization of a splenic artery aneurysm.The anatomy was very tortuous.During the procedure, resistance was felt during advancement of the delivery wire through the direxion microcatheter.The physician did not attempt deployment, but while attempting to retrieve the coil to reposition, the delivery wire detached at the two white deployment markers.After detachment of the proximal release perforation on the delivery wire, the coil remained attached to the pull wire.There was difficulty retracting the pull wire.To complete deployment, the coil was pushed out with a non-boston scientific guidewire, and the microcatheter was removed.A fogarty balloon was inserted and inflated inside the 5fr diagnostic catheter to advance the coil as far inside the nest.The physician attempted to retrieve the pull wire from the sheath, but it broke off outside, so multiple attempts were made to push the pull wire outside of the microcatheter.Approximately 150cm of the pull wire remained inside the patient's body with the embold coil.The case was successfully completed with the pull wire remaining inside the splenic artery.No patient complications were reported.

• 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: 20510039
• Report Number: 2124215-2024-66187
• Device Sequence Number: 13033573
• Product Code: KRD
• UDI-Device Identifier: 08714729983705
• UDI-Public: 08714729983705
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 0033467708
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 02/21/2024
• 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