(b)(4).Investigation result: the returned nephromax balloon device was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also observed that the balloon was torn longitudinally from the proximal of the distal markerband extending proximal of the distal markerband.No problems were identified to the balloon material and markerbands.A visual and tactile examinations revealed that there were no problems found to the tip and the shaft of the device.The reported event was confirmed.It is possible that the device had interaction with a stone, leading to the found problem of balloon torn longitudinally.Therefore, the most probable root cause is adverse event related to procedure because 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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
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