It was reported that the procedure was to treat a lesion in the left mid superficial femoral artery (sfa) with 100% stenosis and mild calcification.The 4.0x120mm armada 14 balloon catheter was advanced to the target lesion and inflated once at 8 atmospheres (atms).Contrast mix was 70% saline and 30% contrast.During deflation, the balloon would not deflate when the inflation device pulled negative.The inflation device was switched to a 30ml syringe, negative was held for 40 seconds and the balloon was slowly deflated.The balloon was withdrawn ultimately deflated.There was no issue with the inflation device as it was used successfully throughout the procedure.There was no resistance removing the deflated balloon.There was no difficulty removing the stylet or protective sheath and the device was prepared (air aspiration) outside the anatomy prior to use.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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A visual, dimensional, and functional analysis was performed on the returned device.The reported deflation issue was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation was unable to determine a cause for the reported deflation issue.It was reported that the contrast mix used in this event was 70% saline and 30% contrast.It should be noted that the armada 14 instruction for use (ifu) lists material required with a contrast mix of 60% contrast diluted 1:1 with normal saline.In this event, it could not be determined if the contrast/saline mix ratio caused or contributed to the difficulty.It may be possible that the distal shaft was bent or entrapped within the anatomy causing the deflation lumen to become closed off; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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