The returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned device revealed a fine jet of water in the distal balloon part when applying a pressure.The microscopic analysis of the balloon surface showed a microscopic leakage and scratches on the balloon surface nearby the damage site.It seems likely that the damage of the balloon surface was caused by a hard, sharp edged object pressing against the balloon from the outside.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all inprocess and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.
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