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); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke, and there was an unretrieved device fragment.An 8x20 embold fibered detachable coil system was selected for use in the embolization of a splenic artery aneurysm, which was accessed via radial approach.Multiple coils, including non-boston scientific coils and interlock, were used to treat.While positioning the last 8x20 embold fibered, the physician was not satisfied with the final placement of the last 3cm of the coil, and a resistance was felt.Therefore, an attempt was made to retract the coil to better position it, but a resistance was felt.The detachment mechanism was never touched or activated.The coil stretched and likely broke at the coil to coupler weld.Many devices (snares, tulip, and other tools) were used to try and remove the device.Since a snare was able to remove 3/4 of the coil tail, the coil likely broke again somewhere on the length during that snare removal.After two hours, the physician decided to leave the remaining 1/4 of the coil inside the splenic artery and celiac trunk.The patient's status was stable post procedure.There is no plan to remove the fragment at a future date.The patient will be under surveillance.

• 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: 16253890
• Report Number: 2124215-2023-03149
• Device Sequence Number: 5350697
• Product Code: KRD
• UDI-Device Identifier: 08714729983620
• UDI-Public: 08714729983620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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: 07/26/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029843709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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: Unknown