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); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was protruding from the target location.A 22mm x 60cm embold fibered detachable coil system was selected for use in the embolization of a type ii endoleak aneurysm coming off of the inferior mesenteric artery (ima).This was the final coil to be placed inside the aneurysm sac.The coil was advanced through the introducer and microcatheter.The delivery wire was retracted in order to reposition the coil, which was starting to move into the point of origin.Upon retracting, resistance was felt while pulling.After reviewing the imaging, the coil appeared to be stretched out but still inside the microcatheter.The microcatheter was flushed and a 0.035-inch wire was used in order to push the coil through the microcatheter.The coil was implanted with approximately 20 cm of the stretched portion of the coil remaining inside the ima but outside the aneurysm sac.The procedure was successfully completed.No patient complications were reported.
Event or Problem Description
It was reported that the coil was protruding from the target location.A 22mm x 60cm embold fibered detachable coil system was selected for use in the embolization of a type ii endoleak aneurysm coming off of the inferior mesenteric artery (ima).This was the final coil to be placed inside the aneurysm sac.The coil was advanced through the introducer and microcatheter.The delivery wire was retracted in order to reposition the coil, which was starting to move into the point of origin.Upon retracting, resistance was felt while pulling.After reviewing the imaging, the coil appeared to be stretched out but still inside the microcatheter.The microcatheter was flushed and a 0.035-inch wire was used in order to push the coil through the microcatheter.The coil was implanted with approximately 20 cm of the stretched portion of the coil remaining inside the ima but outside the aneurysm sac.The procedure was successfully completed.No patient complications were reported.It was further reported that tortuosity was mild.When reviewing the imaging, the coil appeared to be stretched with the coil still inside the microcatheter and only a part of the coil was out of the microcatheter.However, the coil could not be removed due to the resistance felt while pulling.Pushing the coil out through the microcatheter was determined to be the only option at that point.After deploying the coil, it was determined to be safer to not try and correct the coil's position.

• 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: 18105313
• Report Number: 2124215-2023-63146
• Device Sequence Number: 7612099
• Product Code: KRD
• UDI-Device Identifier: 08714729983743
• UDI-Public: 08714729983743
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0032211521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown