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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83910
Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/19/2022
Event Type  Injury  
Event 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 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.
 
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.
 
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Brand Name
EMBOLD FIBERED DETACHABLE COIL SYSTEM
Type of Device
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 Key15417151
MDR Text Key299843861
Report Number2124215-2022-34809
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729983576
UDI-Public08714729983576
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number83910
Device Catalogue Number83910
Device Lot Number0029394547
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
Patient SexMale
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