Product summary analysis: data files were returned and analyzed.Data files showed that two injections were performed with the balloon catheter and inflation did not sustain at the second injection.Also, failure files showed a system notice indicating that the system detected an electrical component failure on the date of the event.In conclusion, the reported issue of an inner balloon lumen kinked was not confirmed through data analysis.The physical device was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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