(b)(6) 2018 - corrected device problem code.The returned instrument 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 revealed that the balloon has been in- and deflated.Microscopic inspection revealed a pinhole about 2 mm proximal to the distal x-ray marker and scratches were found nearby the damage site.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 manufacturing or material root cause was determined.
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