For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Balloon rupture, and peeling pebax was confirmed for the device.A root cause has not been determined.The device was labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model dr8064.Pta balloon dilatation catheter allegedly experienced material rupture and peeled.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
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