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 the reported event.In the as-returned condition the balloon of the complaint instrument is not well folded anymore and has clearly been inflated.An inflation device filled with water was attached to the luer port of the inflation lumen and pressure was applied.Water was found leaking from the luer port of the guidewire lumen.Inside the hub a less than 1 mm cut was detected in the inner shaft, indicating penetration with a sharp-edged object.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leak test.All tested instruments passed these tests.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on these findings it seems likely that the root cause for the complaint event is related to external factors during the procedure or its preparations.
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