It was reported that during the procedure, the dragonfly optis imaging catheter was leaking contrast from a hole at the tip of the device while being used in the patient.The device was removed, and a new dragonfly device was used successfully for the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
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Visual analysis and functional testing were performed on the returned device.The reported leak and ¿a hole at the tip of the device¿ were unable to be confirmed, as the returned device was able to be purged as expected with purged liquid exiting the designated purge hole.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the cause for reported leak and ¿a hole at the tip of the device¿ were unable to be confirmed.The catheter was returned with dried contrast visible throughout the entirety of the sheath, so the catheter was placed into a water bath in attempt to remove the dried contrast.After the water bath, purging liquid through the catheter was attempted again and the purged liquid was able to flow freely through the sheath, as expected, and exited through the purge hole.There was no damage/hole noted to the catheter distal tip, and liquid exited proximally from the distal tip and through the dedicated purge hole.It should be noted that optis and opstar model catheters have a dedicated purge hole located proximal to the guidewire exchange minirail, on the distal portion of the sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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