The lot number was provided, therefore a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model u41501h12rx ultra verse rx pta dilatation catheter allegedly experienced material deformation and failure to advance.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender of the patient was not provided.
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