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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