BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number 83910 |
Device Problems
Break (1069); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
Injury
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Event Description
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It was reported that the coil broke, requiring additional intervention.A 3mm x12cm embold fibered detachable coil system was selected for use in a hemorrhoid embolization procedure.The coil was partially deployed in the rectal artery branch when an attempt was made to reposition; however, resistance was encountered while both pushing and pulling on the delivery wire.An attempt was made to retrieve the coil into the microcatheter.The operator pulled with resistance, and the coil stretched and ultimately broke.The coil separated from the couplers on the delivery wire.Multiple passes were made with both standard 6f snares and microsnares to retrieve portions of the stretched coil.The patient fully recovered.
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Event Description
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It was reported that the coil broke, requiring additional intervention.A 3mm x12cm embold fibered detachable coil system was selected for use in a hemorrhoid embolization procedure.The coil was partially deployed in the rectal artery branch when an attempt was made to reposition; however, resistance was encountered while both pushing and pulling on the delivery wire.An attempt was made to retrieve the coil into the microcatheter.The operator pulled with resistance, and the coil stretched and ultimately broke.The coil separated from the couplers on the delivery wire.Multiple passes were made with both standard 6f snares and microsnares to retrieve portions of the stretched coil.The patient fully recovered.It was further reported that the coil appeared to separate between the coil and the distal coupler before multiple passes with snares were made to remove the stretched coil.The remaining coil fragments were left in the non-target inferior mesenteric artery.Approximately how much of the coil was left in the patient was unable to be determined due to the stretched length.The procedure was not completed with another coil, and the target location did not appear sufficiently embolized.
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