Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Block g2 update: china block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation and magnification noted that bladder coil was detached, the detached part looks stretched, and the detached piece of the stent was not returned.Additionally, the suture was not returned.No other problems with the device were noted.The reported event was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached during the procedure affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
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