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 leaking from the guidewire exit port.Microscopic analysis revealed a damage of the inflation lumen distal to the guidewire exit port with a shape of a longitudinal sharp cut from inside of the guidewire lumen over a length of 1 mm.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 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 damage of the guidewire lumen was most likely caused by a sharp object.
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