Investigation ¿ evaluation.One used balloon catheter with inflation device and seven unopened devices were returned for investigation.Using the returned inflation device, the balloon was inflated using water.A visual examination noted a leak.Under microscopic magnification, the leak was noted at the edge of the proximal glue bond.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record was performed.There were no non-conformances noted during the manufacturing process.A clinical assessment was performed.Per the user report, the stone was in the ureter renal pelvis junction that was deeper expansion distance and met big resistance when inflating the balloon which caused the bleeding of the blood vessel in the renal hilum.The user tried to change the puncture channel but it failed too.The user failed to repair and ultimately removal of the kidney was done.The resistance was encounter due to the pre-existing large kidney stone.The balloon inflation plus high resistance encountered from the stone may have resulted in the blood vessel damage; hence increase level of bleeding.Based on the available information the exact cause of the reported issue is not clear; however, it is feasible to suggest this may have been contributed to the user technique/procedure than the malfunction of the device.The device is shipped with instructions for use (ifu), which states the proper warnings, precautions, and instructions for use.The ifu specifically states "do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture." the ifu also states under potential adverse events section "complications that might occur during this procedure include over inflation of the balloon, which could result in trauma to the surrounding tissue." per the quality engineering risk assessment, measures have been initiated to address this failure mode.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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