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)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke and there were unretrieved device fragments.An 18mm x 50cm embold fibered detachable coil system was selected for a hepatic artery embolization to treat a hepatic artery aneurysm.The vessel was significantly tortuous.During the procedure while deploying the fourth coil with intermittent flushing, the coil had partially deployed in the sac and then was attempted to deploy back into the artery feeding the pseudoaneurysm.During coil retraction, a lot of resistance was felt.Thinking that the coil prematurely detached, the physician continued to pull back on the nitinol pusher wire.They found that the coil was still attached to the pusher and the coil had unraveled inside the patient.While continuing to pull, the coil continued to unravel until it eventually snapped.Multiple attempts were made at snaring the coil for retrieval as a single piece and was unsuccessful.A combination of micro snare and forceps were used to remove the coil fragments in pieces.The right common femoral artery access was upsized and a snare was then used to capture remaining fragments of coil within the aorta.Not all pieces were retrieved successfully, and partial pieces of the coil were left inside the common hepatic and splenic arteries of the patient.There were no further complications, and the patient was expected to fully recover.
Additional Manufacturer Narrative
'the vessel was significantly tortuous.' corrected to 'the vessel was moderately tortuous.' 'during coil retraction, a lot of resistance was felt.' corrected to 'mild resistance was felt during coil retraction.' device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered coil 18x50.The delivery wire returned with the couplers attached.Visual and microscopic analysis was conducted.The perforations were intact.The distal and proximal couplers were attached to the delivery wire via the pull wire.The coil was separated from the distal coupler and was severely stretched and tangled.The distal coupler showed bend damage.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for advancing issues, kinks, coupler damage, and a stretched damaged coil.
Event or Problem Description
It was reported that the coil broke and there were unretrieved device fragments.An 18mm x 50cm embold fibered detachable coil system was selected for a hepatic artery embolization to treat a hepatic artery aneurysm.The vessel was significantly tortuous.During the procedure while deploying the fourth coil with intermittent flushing, the coil had partially deployed in the sac and then was attempted to deploy back into the artery feeding the pseudoaneurysm.During coil retraction, a lot of resistance was felt.Thinking that the coil prematurely detached, the physician continued to pull back on the nitinol pusher wire.They found that the coil was still attached to the pusher and the coil had unraveled inside the patient.While continuing to pull, the coil continued to unravel until it eventually snapped.Multiple attempts were made at snaring the coil for retrieval as a single piece and was unsuccessful.A combination of micro snare and forceps were used to remove the coil fragments in pieces.The right common femoral artery access was upsized and a snare was then used to capture remaining fragments of coil within the aorta.Not all pieces were retrieved successfully, and partial pieces of the coil were left inside the common hepatic and splenic arteries of the patient.There were no further complications, and the patient was expected to fully recover.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered coil 18x50.The delivery wire returned with the couplers attached.Visual and microscopic analysis was conducted.The perforations were intact.The distal and proximal couplers were attached to the delivery wire via the pull wire.The coil was separated from the distal coupler and was severely stretched and tangled.The distal coupler showed bend damage.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for advancing issues, kinks, coupler damage, and a stretched damaged coil.
Event or Problem Description
It was reported that the coil broke and there were unretrieved device fragments.An 18mm x 50cm embold fibered detachable coil system was selected for a hepatic artery embolization to treat a hepatic artery aneurysm.The vessel was significantly tortuous.During the procedure while deploying the fourth coil with intermittent flushing, the coil had partially deployed in the sac and then was attempted to deploy back into the artery feeding the pseudoaneurysm.During coil retraction, a lot of resistance was felt.Thinking that the coil prematurely detached, the physician continued to pull back on the nitinol pusher wire.They found that the coil was still attached to the pusher and the coil had unraveled inside the patient.While continuing to pull, the coil continued to unravel until it eventually snapped.Multiple attempts were made at snaring the coil for retrieval as a single piece and was unsuccessful.A combination of micro snare and forceps were used to remove the coil fragments in pieces.The right common femoral artery access was upsized and a snare was then used to capture remaining fragments of coil within the aorta.Not all pieces were retrieved successfully, and partial pieces of the coil were left inside the common hepatic and splenic arteries of the patient.There were no further complications, and the patient was expected to fully recover.

• 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: 18059426
• Report Number: 2124215-2023-59654
• Device Sequence Number: 6713180
• Product Code: KRD
• UDI-Device Identifier: 08714729983729
• UDI-Public: 08714729983729
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 12/05/2023

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: 07/30/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0032117244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 12/04/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/15/2023; 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4 FR TERUMO PROGREAT.; 2.4 FR TERUMO PROGREAT.; 2.4 FR TERUMO PROGREAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown