KANEKA CORPORATION I-ED COIL SYSTEM; DEVICE, NEUROVASCULAR EMBOLIZATION DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Catalog Number 390-0204 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The returned product is unraveled and in a terrible state, and it is our view that it is caused by the procedure.The following is stated in the package insert to alert people.[precautions] important basic precautions: insert and pull back this product slowly.Causes damage to blood vessels and damage to this product.
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Event Description
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Coil embolism in a patient waiting for vapica lesion (unruptured).When the doctor tried to insert the i-ed coil 2쳌~40mm (the product) by coil embolization with a stent, the tip of the microcatheter sl-10 came out of the aneurysm.Therefore, when the product was collected without being placed, the coil part was unraveled.After the coil was recovered, another stent was placed and the case was completed.The product was returned to us.When the actual product was investigated, it was found that the unraveled coil was cut and the tip side was missing.
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