Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A visual evaluation of the returned device found that stent was broken 17 cm from the renal pigtail.The broken section was inspected under magnification, and no smooth surfaces were noticed over the fracture zone, which indicates that the stent was not broken due to mechanical cut.Based on the product analysis, it is most likely that anatomical/procedural factors were encountered during the procedure which may have limited the overall performance of the device.The failure noted was most probably caused due to the force used (torcion generated) when the stent was pulled out from the patient's body.Additionally, this failure is consistent with one caused by the suture when it is being pulled, or due to the forceps use during the stent removal.Therefore, the most probable root cause selected for the complaint is "operational context".A dhr (device history record) review was performed and no deviation was found.A labeling review was performed and no anomalies were found.
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It was reported to boston scientific corporation that a polaris¿ loop ureteral stent was implanted in the kidney during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the coil of the stent detached inside the patient.The detached piece was successfully retrieved from the patient using forceps.The procedure was completed with another polaris¿ loop ureteral 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 ¿stable¿.
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