Product event summary: the device and data files were returned and analyzed.Bin files showed at least 13 applications were performed with a balloon catheter on the date of the event with no issues.Visual inspection of the sheath showed that the shaft was bent/ kinked 0.8 inch from the tip.The sheath was unable to be straightened into place due to a shaft kink.In conclusion, the reported bent sheath issue was confirmed through testing.If information is provided in the future, a supplemental report will be issued.
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