Device evaluation: visual and tactile inspections were carried out on the returned device.The balloon was unfolded and showed a twist 3 cm from the proximal balloon welding.The 0,018¿¿ guide wire was loaded without any issue.During the analysis, negative pressure was applied with a manometric syringe on the balloon: the purging test passed, since no bubbles emerged in the water column.Afterwards, the balloon was inflated sequentially at: - 1 bar: the balloon was showing wrinkles in correspondence of the twist; - 2 bar: no wrinkles detected - 7 bar: no wrinkles detected - 14 bar: no wrinkles detected.No twist was present on the guide wire lumen.Results: the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.Conclusion: the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device.Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion.
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