The returned product 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 revealed a fine jet of water emerging from the distal end of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole direct distal to the distal x-ray marker.In close vicinity of the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each product is tested for air tightness by means of a pressure test and a helium leak test.We can therefore confirm that the product was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause was determined.The root cause for the reported event is most likely related to the patients anatomy.
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