Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 014 pta dilatation catheter was returned for evaluation.Balloon twisting was able to be observed on the retuned device.No other specific anomalies noted during the visual evaluation.On the functional evaluation, the guide wire lumen was flushed and an in-house guide wire was able to insert and remove through the catheter without any issue.Further, the balloon was inflated with an in-house presto inflation device and water was noted to be leaking from the balloon.Under microscopic observation it was noted a longitudinal rupture.No further testing was performed.Therefore, the investigation for reported unable to cross lesion remains inconclusive as the condition of use could not be reproduced on the laboratory condition.However, the investigation was confirmed for an identified balloon twist as the twisted balloon was able to observe during the visual evaluation of the returned sample.The investigation was also confirmed for identified balloon rupture as a longitudinal balloon rupture was observed under the microscope and water also leaks from the balloon during the functional testing.A definitive root cause for the reported unable to cross lesion, identified balloon twist and balloon rupture could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.
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