The lot number for one of the two reported malfunctions was provided and a lot history review was performed.The device for one malfunction was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.For the other malfunction, the device was returned and the investigation identified peeled outer layer.The definitive root cause is unknown.The devices are labeled for single use.
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This report summarizes two malfunctions.A review of the reported information indicated that model u4102h30 pta balloon dilatation catheter allegedly experienced peeled material.This information was received from various sources.Both events involved a patient with no reported patient injury.Patient age, weight, and gender were not provided.
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