As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunction is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
|
This report summarizes one malfunction.The information reviewed indicated that model u357584 pta balloon dilatation catheter allegedly experienced material rupture and retraction problem.The information was received from one source.The malfunction involved a patient with no reported consequences.Age, weight, and gender were not provided.
|