The lot number was provided and a lot history review will be performed.
The sample was returned for evaluation.
Inflation issues, material deformation, and detachment were identified during the evaluation.
The root cause could not be 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 u4150215rx, pta dilatation catheter, allegedly experienced an inflation issue.
This information was received from a single source.
This malfunction involved a patient with no consequences.
The patient's age, weight, and gender were not provided.
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