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.The technical investigation revealed that both the braided outer shaft and the stabilizer shaft are kinked and deformed.The stabilizer shaft has wrinkled at the transition to the handle lever.The damage pattern indicates that the braided outer shaft has been pulled too far back into the stabilizer shaft and was thus blocked from movement, inducing a wrinkling of the blue stabilizer shaft at the transition to the handle lever.This may slightly affect mobility of the guidewire in the guidewire lumen.However, the distal shaft deformations have probably contributed to the reduced mobility.A 0.018 inch reference guidewire could be introduced into the guidewire lumen of the returned instrument without unusual friction.The guidewire used in the intervention was not returned for analysis.A simulation was conducted with a reference pulsar-18 t3 and 0.018 inch guidewire.After inducing a damage of the stabilizer shaft as seen in the complaint instrument slightly increased friction was felt when moving the guidewire in the guidewire lumen, but it was not blocked.Review of the production documentation confirmed that the device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.
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