H6: imdrf device code a0406 captures the reportable investigation finding of side car rx pushback.H10: the returned trapezoid rx basket was analyzed, and a product analysis observed the side car rx was torn and pushed back.The reported event was confirmed.With all the available information, the problems of side car rx could have occurred due to excessive manipulation or force applied to the handle when trying to open the basket.Additionally, if a guidewire was used through the side car rx and got stuck, attempts to pull it out could cause the side car rx to tear or become pushed back.Therefore, the most probable root cause is adverse event related to procedure.
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