(b)(4).The returned percuflex urinary diversion stent was analyzed, and a visual evaluation noted that the shaft was detached or separates and only apportion of the shaft with the renal pigtail was returned and no kinks were observed.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was found that the device has the shaft detached or separated and turn black.According to the evidence, it is possible that operational factors, such as interacting of the device with other device, or handling or manipulating during it use could have caused this failure.Consequently affect the performance of the device.Review and analysis of all available information indicated that the root cause of the problems found is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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It was reported that a percuflex urinary diversion stent was used during a stent implantation procedure in the ureter performed on (b)(6) 2021.During procedure, it was found that one of the pigtail coils was slightly bent and could not be implanted.The procedure was successfully completed with another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be as no patient injury.Please note, this has become reportable based on investigation results.
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