It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with mild calcification, mild tortuosity and 85% stenosis.The indeflator was connected directly to a balloon; however, there was a loose connection.During inflation, an air bubble was noted in the gauge.It was attempted to tighten the loose connection but when inflation was attempted again, air bubbles were found.A non-abbott inflation device was used to complete the procedure.No air was found in the other inflation device during the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.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 did not indicate a lot specific quality issue.It is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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