Event description was updated on may 02, 2018: as reported the elunir 3.0x28 and elunir 3.0x17 us balloons would not remove easily after deployment, even after the balloons were deflated.There was no patient injury reported and products will not be returned for analysis.Additional information received on may 03, 2018: after several attempts the balloon catheter was then removed.Took a couple of tugs for it to be removed.About 30 seconds.The balloon catheters were not removed easily, they were stuck at lesion site after deployment and were removed by continuous wiggling and tugging.The products were stored and handled according to the instructions for use (ifu); no damage was noted to the packaging of the devices; the devices were stored the whole time in the cath lab in a cart; there was no difficulty removing the products from the hoop; there was no difficulty removing the protective balloon covers; there was no difficulty removing the stylet or any of the sterile packaging components; no kinks or other damages were noted prior to inserting the products into the patient; the devices were preped normally (i.E.Maintain negative pressure); the used contrast media was omnipaque; the contrast to saline ratio: 50/50; the same indeflator was used successfully with other devices; there was no resistance/friction while inserting the balloons through the guide catheter.Vessel / lesion characteristics : severe calcified lesion and vessel; there was no difficulty advancing the balloon catheters through the vessel; there was no difficulty crossing the lesion; the balloons deflated normally; the balloon catheters were not kinked while being used; the products were removed intact (in one piece) from the patient; no patient injury occur.The current status of the patient is stable.Additional information received on may 06, 2018: the physician did not try to re-inflate the balloon as instructed in the ifu.
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