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 received for evaluation.A visual inspection found peeled pebax, and fiber disturbance on the balloon.The device was inflated and water was seen exiting the balloon.The fibers were stripped away and a longitudinal rupture was noted on the balloon.Therefore, the investigation is confirmed for peeled pebax, fiber disturbance, and for a longitudinal rupture.The root cause for the reported rupture or identified fiber and pebax issues could not be determined based upon available information.It is unknown whether patient and/or procedural factors 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.
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