It was reported that the physician utilized the universa soft ureteral stent set with large stone burdens during a ureteroscopy.The stent broke up the stones; however, there were still fragments.The stent was completely pinched off and led to hydronephrosis (ballooning effect of the kidney).The physician admitted that it may have been due to the large stone burden.The stent and stone fragments were removed and a new stent was placed which worked successfully.A section of the device did not remain inside the patient¿s body.The patient did require an additional procedure due to this occurrence.The patient had to have the stones removed and a new stent placement.According to the initial reporter, the patient did experience an adverse effects due to this occurrence.Since the stent was pinched; it caused hydronephrosis.Patient has had no further complications from this incident.
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(b)(4).Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.No lot number was provided so additional product of the same lot could not be pulled from stock for analysis.The investigation included a review of the instructions for use, quality control data, and specifications.A review of the device history record could not be performed as the lot number of the device was not provided.A search for additional complaints on the same lot could not be carried out without the device lot number.The instructions for use (ifu) provides the following information: individual variations of interaction between stents and the urinary system are unpredictable.Ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.Complications of ureteral stent placement are documented.These complications include, but are not limited to: ¿ extravasations ¿ occlusion ¿ migration ¿ hemorrhage ¿ sepsis ¿ perforation of the urinary tract ¿ peritonitis ¿ encrustation ¿ urinary tract infection ¿ loss of renal function occlusion of the ureteral stent is mentioned as a potential adverse event in the ifu and is a known inherent risk of the device.A document review was carried out and no anomalies could be found with production or inspection process.A clinical assessment was carried out that concluded that the most probable causes of this event are human anatomy or disease progression related.However, device failure and medical procedure related causes cannot be entirely ruled out.The complaint report included comments from the physician who indicated that the large stone burden in the patient may have contributed to the complaint event.Based on the available information the probable cause is the patient¿s anatomy or disease progression.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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