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); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an unretrieved device fragment.A 4mm x 15mm embold fibered detachable coil system was selected for use in a splenic pseudoaneurysm embolization procedure.The splenic artery was moderately tortuous, and there were a lot of issues with base stability.Eventually, a truselect catheter was placed distal to the pseudoaneurysm, and coiling began with 5mm embolds.Next, a 10mm x 20mm embold was placed despite difficulty going around the tortuosity and microcatheter kick back.Some non-boston scientific low-profile packing coils were placed followed by 4-5mm embolds further back.Finally, a 4mm x 15mm embold was positioned, but there was a detachment issue.When the wire between the perforation markers was snapped, the pull wire snapped as well.There was no pull wire to grasp at all.An attempt was made to remove the coil, but the distal end of the delivery wire was kinked and would not come back across the tortuous vessel.The physician ended up cutting the proximal end of the delivery wire until the pull wire was visible.The pull wire was pulled, and the coil was finally released, but it was suspected the proximal coil marker from the polymer shaft was left inside the patient.The procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that there was an unretrieved device fragment.A 4mm x 15mm embold fibered detachable coil system was selected for use in a splenic pseudoaneurysm embolization procedure.The splenic artery was moderately tortuous, and there were a lot of issues with base stability.Eventually, a truselect catheter was placed distal to the pseudoaneurysm, and coiling began with 5mm embolds.Next, a 10mm x 20mm embold was placed despite difficulty going around the tortuosity and microcatheter kick back.Some non-boston scientific low-profile packing coils were placed followed by 4-5mm embolds further back.Finally, a 4mm x 15mm embold was positioned, but there was a detachment issue.When the wire between the perforation markers was snapped, the pull wire snapped as well.There was no pull wire to grasp at all.An attempt was made to remove the coil, but the distal end of the delivery wire was kinked and would not come back across the tortuous vessel.The physician ended up cutting the proximal end of the delivery wire until the pull wire was visible.The pull wire was pulled, and the coil was finally released, but it was suspected the proximal coil marker from the polymer shaft was left inside the patient.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered 4x15.The delivery wire and the nitinol shaft were returned outside of the delivery sheath.The returned delivery wire showed that it was not broken at the serration.The coupler showed a slight bend and was still connected to the delivery wire.The pull wire showed a break.The ro marker was still attached to the delivery sheath.The media that was returned showed stretching of the coil.The media review concluded that the coil was inside the patient.The distal coupler was still attached per the image returned.The coupler appeared to be attached to the coil and may have been stretched.

• 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: 15417151
• Report Number: 2124215-2022-34809
• Device Sequence Number: 2786016
• Product Code: KRD
• UDI-Device Identifier: 08714729983576
• UDI-Public: 08714729983576
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/02/2022

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: 05/12/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029394547
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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 Age: 68 YR
• Patient Sex: Male