Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.The returned trapezoid rx was analyzed, and a visual inspection observed that the sheath was buckled and detached at the proximal section and the side car rx was pushed back.A functional test was performed, and the basket could not open due to the coil being detached.The reported event was confirmed.The detached coil and the damage to the sheath indicate a possible elongation of the coil when trying to open the basket.Based on all the information available, excess force applied in conjunction with the patient's anatomical condition could have contributed to the event; therefore, the most probable root cause is adverse event related to procedure.
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