Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the peeling of the outer pebax layer and frayed fibers on the proximal cone of the balloon.The device was inflated and water was seen exiting the balloon from a longitudinal rupture.Therefore, the investigation is confirmed for both peeled pebax and fiber disturbance, as well as for a longitudinal rupture.The definitive root cause for the identified rupture or peeling and fiber issues could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date - 04/2021.
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