Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx pushback.Block h10: the returned trapezoid rx was analyzed, and the product analysis observed the side car rx was torn and pushed back by 3.5 mm.The reported event of side car rx torn was confirmed.Based on all available information, the reported clinical observation and the additional investigation finding of side car rx pushback could have occurred due to the technique used, patient's anatomical conditions, or due to excessive manipulation when trying to open the basket.Additionally, it is possible that these problems could have been generated if there was difficulty removing the guidewire from the side car.Therefore, the most probable root cause is adverse event related to procedure.
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