The returned device was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned pantera leo revealed a longitudinal tear in the distal half of the balloon.Further microscopic analysis showed several deep scratches on the balloon surface at several locations.The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The balloon burst in longitudinal direction was most likely induced by the severely calcified lesion.
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