Block h6: imdrf device code a0406 is being used to capture the reportable investigation result of side car rx push back.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection observed that that the side car rx was pushed back and buckled.A dimensional test confirmed that the side car rx was pushed approximately 4 mm, which is out of specification.A functional test performed, and the basket was able to open accordingly.The reported event of basket failure to open was not confirmed.Based on available information, the side car rx push back and buckled accordion could have occurred due to excessive manipulation attempting to open the stuck basket.The technique used, or patient's anatomical condition could have contributed to this event.Therefore, the most probable root cause for the problems found during analysis is adverse events related to procedure.However, the reported event of basket failure to open was not confirmed during analysis as the basket was able to open properly.Therefore, the root cause for the reported problem is no problem detected.
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