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process could be the cause for the reported event.The technical investigation revealed that the outer shaft has been retracted by about 160 mm and the stent has been fully released.The winding wheel at the handle could not be further rotated.After opening the handle it became apparent that the pull wire has not been correctly routed.This caused an entanglement of the pull wire with the winding wheel as well as a blockage of the hose at the proximal end of the pull wire.A simulation with a reference pulsar-18 t3 showed that the same damage pattern could be reproduced by wrongly routing the pull wire inside the handle.These findings indicate that the root cause for the complaint event is most likely related to the manufacturing process, i.E.Assembly of the handle.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.
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