(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis and abbott vascular (av) confirmed the reported difficulty in deflating the balloon.A review of the complaint handling database found no similar incidents from this lot.Av conducted a thorough root cause analysis and determined the deflation issue is potentially related to manufacturing.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.
|
It was reported that the patient underwent a peripheral procedure, treating a target lesion in the right iliac artery.The armada 35 dilatation catheter was advanced to the target lesion and was inflated 1 time, to 18 atmospheres (atm) and deflated without issue.The device was inflated a second time, to 18 atm, but deflated slowly.Difficulty was noted removing the device, and upon removal, the balloon was noted to have bunched up towards the tip of the device.A second unspecified dilatation catheter was used, and was followed by stenting.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
|