Evaluation summary: the device was returned the original box.The data on the luer was consistent with lot number indicated in the product complaint form.Visual and tactile inspections were performed.No damages have been noted on the shaft.The balloon was used.A twisted area was noted on the balloon 11 cm from the tip.It was not possible to insert the 0,018¿¿ guide wire because there was hardened blood inside the guidewire lumen.The purging procedure was performed with no issues.The balloon was inflated at 2 bar and its profile resulted deformed in the point of twisting.At 14 bar it was also possible to note a deformation point on the guide wire tube just below the wrinkled area, identified as point of twist.No further issues found.Additional information received: the devices were moved and repositioned during the procedure but the twists did not go away.If information is provided in the future, a supplemental report will be issued.
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