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 a partial break at the proximal balloon butt joint.Additionally, slight fiber disturbance was noted on the balloon.Therefore, the investigation is confirmed for break and fiber disturbance.The device was inflated and a leak was noted at the location of the fiber disturbance.Upon further examination, the leak was originating at a pinhole rupture in the balloon.Therefore, the investigation is confirmed for the reported leak due to a pinhole rupture.No leaking was noted at the partial break in the butt joint.The identified pinhole rupture was the cause of the reported leak from the balloon.However, the definitive root cause for the rupture or identified butt joint break and fiber disturbance could not be determined based on 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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