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

Model Number	83910
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the proximal end of the coil protruded to a non-target vessel causing non-targeted embolization, requiring an attempted snaring of the device, and hospitalization.This 14x50 embold fibered detachable coil system was selected for use in an endoleak embolization procedure.During the procedure, the coil became difficult to advance approximately 30cm into the distal part of the microcatheter.It was retracted and it was believed that the coil became detached at the coupler, stretching approximately 100cm and becoming entangled.The microcatheter was removed and the distal end of the coil remained in the targeted vessel; however, the proximal end protruded into the branches of the superior mesenteric artery (sma), causing non-target embolization.It was noted the target vessel was moderately tortuous.An attempt had been made to snare the coil without success.The procedure was completed, the patient was hospitalized for observation.No additional interventions were required and the endoleak sac was successfully embolized.
Additional Manufacturer Narrative
The attached medwatch reported the information which is noted in the additional narrative in b5: describe event or problem.However, information was received from the field representative which confirmed the events occurred as they were previously reported.
Event or Problem Description
It was reported that the proximal end of the coil protruded to a non-target vessel causing non-targeted embolization, requiring an attempted snaring of the device, and hospitalization.This 14x50 embold fibered detachable coil system was selected for use in an endoleak embolization procedure.During the procedure, the coil became difficult to advance approximately 30cm into the distal part of the microcatheter.It was retracted and it was believed that the coil became detached at the coupler, stretching approximately 100cm and becoming entangled.The microcatheter was removed and the distal end of the coil remained in the targeted vessel; however, the proximal end protruded into the branches of the superior mesenteric artery (sma), causing non-target embolization.It was noted the target vessel was moderately tortuous.An attempt had been made to snare the coil without success.The procedure was completed, the patient was hospitalized for observation.No additional interventions were required and the endoleak sac was successfully embolized.Per mw5156466, it was further reported that this 14x50 embold fibered detachable coil system was passed through the microcatheter; however, upon retraction of the catheter tip into the inferior mesenteric artery with gentle advancement of the detachable coil, the decision was made to remove the coil prior to deployment.Gentle retraction on the coil was being performed when there was an unexpected shearing of the deployment system within the microcatheter.The distal aspect of the detachable coil was removed; however, it was evident that the coil was still within the microcatheter in the middle to distal aspect of the arc of riolan.
Event or Problem Description
It was reported that the proximal end of the coil protruded to a non-target vessel causing non-targeted embolization, requiring an attempted snaring of the device, and hospitalization.This 14x50 embold fibered detachable coil system was selected for use in an endoleak embolization procedure.During the procedure, the coil became difficult to advance approximately 30cm into the distal part of the microcatheter.It was retracted and it was believed that the coil became detached at the coupler, stretching approximately 100cm and becoming entangled.The microcatheter was removed and the distal end of the coil remained in the targeted vessel; however, the proximal end protruded into the branches of the superior mesenteric artery (sma), causing non-target embolization.It was noted the target vessel was moderately tortuous.An attempt had been made to snare the coil without success.The procedure was completed, the patient was hospitalized for observation.No additional interventions were required and the endoleak sac was successfully embolized.Per mw5156466, it was further reported that this 14x50 embold fibered detachable coil system was passed through the microcatheter; however, upon retraction of the catheter tip into the inferior mesenteric artery with gentle advancement of the detachable coil, the decision was made to remove the coil prior to deployment.Gentle retraction on the coil was being performed when there was an unexpected shearing of the deployment system within the microcatheter.The distal aspect of the detachable coil was removed; however, it was evident that the coil was still within the microcatheter in the middle to distal aspect of the arc of riolan.
Additional Manufacturer Narrative
In emdr report supplemental -001, attached medwatch mw5156466-reported the information which is noted in the additional narrative in b5: describe event or problem.However, information was received from the field representative which confirmed the events occurred as they were previously reported.In this emdr report supplemental -002- attached medwatch mw5156853.

• 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: 19562971
• Report Number: 2124215-2024-36307
• Device Sequence Number: 7606002
• Product Code: KRD
• UDI-Device Identifier: 08714729983712
• UDI-Public: 08714729983712
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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 Expiration Date: 04/16/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031435460
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 07/25/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/05/2024; 08/22/2024
• Date Device Manufactured: 04/17/2023
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White