The lot number was provided for the reported malfunction and a lot history review was performed.One device was returned for evaluation.The investigation confirmed for inflation issue, leak, and break.A root cause could not be determined.The device is labeled for single use.
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This report summarizes one malfunction.The information reviewed indicated that model dr8098 pta balloon dilatation catheter allegedly experienced inflation issue, break, and a leak.This information was received from one source.The malfunction involved a patient with no reported consequences.Age, weight, and gender were not provided.
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