Block h6: imdrf device code a0401 captures the reportable investigation results of stent detached or separated.Block h10: the returned percuflex urinary diversion stent was analyzed, and a magnification and visual evaluation noted that the coil was kinked, and the stent shaft was detached.Additionally, the detached part was not returned.No other problems with the device were noted.The reported event of stent kinked was 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 probable that the problem was caused due to the interaction between the guidewire and the stent, such as the handling of the device could have contributed with the complaint event reported.Regarding the reported problem of stent shaft detached, based on the irregular shape of the detached tip, there is enough evidence to conclude that the device was cut.For that reason, the as analyzed cause code is unintended use error cause or contributed to event.Therefore, all compiled information on this investigation determines that the most probable cause is unintended use error cause or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.
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It was reported to boston scientific corporation that a percuflex urinary diversion stent was used during a procedure performed on (b)(6), 2023.During the procedure, the stent was found damaged.It was noted that the stent was kinked.The procedure was successfully completed with another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
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