Event date, describe event or problem, device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: the device was received for analysis.No kinks or damage were visible along the entire length of the device.An examination of the balloon found that the balloon exhibited clear signs of having been inflated and deflated.No tears or holes were present in the balloon material.As part of the functional testing the device was attached to an encore inflation unit and the balloon was attempted to be inflated to its rated burst pressure; however, a drop in pressure was identified when the device reached 12 atmospheres.The droplet leak was visible under the strain relief.The strain relief was removed and leak was found to be coming out from where the shaft enters to moulded hub.Using the same encore inflation unit, liquid was inflated through the wire port in the hub and the shaft was clamped distally along the shaft.No leak was confirmed coming back out the inflation port in the hub.This confirmed that there was no breach between the inflation and the wire lumen.The leak was concluded to be coming out from the hub/shaft connection.The origin of the leak could not be identified.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed. (b)(4).
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