This supplemental report is being submitted to report the device evaluation results, correct the device lot number and provide the device manufacture date.Please the updates in sections: d10, g4, g7, h2, h3, h6 and h10.The device was returned to the service center in the original product box inside a plastic package.A visual inspection was performed and found the basket completely broken off inside a jar.The remaining parts of the basket were also returned; however, were not placed inside the jar with the basket.The basket was returned in the fully retracted position.As the lever is pushed up/forward as would be done to extend the balloon, the distal end of the device began to bunched up as observed on the pictures.It is unclear what may have caused the basket to fully detach from the device.Since the root cause of the basket breakage could not be determined in this evaluation the investigation results were shared with the original equipment manufacturer (oem).The device was not sent back to the oem for evaluation.The oem, epflex reviewed the investigation for this device and reported the following: the oem states was also unable to determine the exact root cause of the fracture.The oem reported that the minimum tensile strength of baskets is 100% tested and that the breakage is likely due to overloading during medical application.The oem performed a dhr review for this device and there was no deviation or irregularity detected.The oem is taking no additional corrective action as a result of this complaint.
|