The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was returned for evaluation.The investigation is identified a foreign material during evaluation.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 cq7586 pta balloon dilatation catheter allegedly experienced foreign material.This report was received from one source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender were not provided.
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