(b)(4).Investigation result a visual examination of the returned complaint device found that the balloon and catheter have no damages.Microscopic analysis was performed, and it was noticed that the balloon had a pinhole, which confirms the reported event of balloon leak.During the microscope inspection the balloon was dissected to inspect the ro markers (distal-proximal) and no defects were noted.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located at the proximal section on the body of the balloon.The most probable cause of the event was caused traced to device design.The balloon pinhole was likely caused by the radiopaque (ro) marker on the device during use.When the hurricane rx biliary balloon dilatation catheter device is used at high elevator angles (>70 degrees, which is a range of angles infrequently used to reach the desired target location), interaction between the device and the scope can contribute to balloon pinholes due to ro marker contact with the balloon.In june 2021, a corrective action was implemented to reduce the potential for similar balloon pinhole events.The corrective action included applying glue around both edges of the ro markers during manufacturing, which adds a protective layer around the ro marker and reduces the potential for balloon pinholes during use.The referenced device was manufactured prior to implementation of this solution.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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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