Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported event of side car - rx pushback.Visual analysis of the returned device found the side car - rx presented pushback out of specification.The evaluation concluded that during the procedure manipulation of the device and interaction with the scope or other devices most likely contributed to the side car - rx pushback.Due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Therefore, the most probable root cause of this complaint is operational context.A review of the device history record (dhr) was performed and no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
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It was reported to boston scientific corporation that a trapezoid¿ rx basket was used during a biliary stone retrieval procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the trapezoid¿ rx basket was used multiple times to remove biliary stones.The side car-rx (guidewire port) became pushed back after multiple insertions of the device were made.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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