An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The storage conditions for these catheters are specified in the ifua capa was previously initiated and used as reference in the evaluation as it addresses the "balloon - latex deterioration" failure for the embolectomy models with a vascupouch packaging.The capa investigation concluded that the root cause is exposure of latex to ozone, which can happen when the pouch packaged device is stored in rooms with high energy ionizing radiation sources that could generate ozone e.G.Fluoroscopy machines, x ray machines, uv lights, hvac sanitation equipment, etc.The storage conditions for these catheters are specified in the ifu.The capa resulted into a voluntary field correction action that instructed customers to return any product which has been stored in the same room as high energy ionizing radiation sources which emit ozone.
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