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 fiber disturbance on the barrel of the balloon.Therefore, the investigation is confirmed for fiber disturbance.The device was inflated and water was seen exiting the balloon fibers.The fibers were stripped away, and a longitudinal rupture was noted in the balloon material.Therefore, the investigation is confirmed for a longitudinal rupture.The definitive root cause for the identified rupture or fiber disturbance could not be determined based upon the available information.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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