During the procedure, a dissection occurred when the catheter was used at the rca lesion with tortuosity.While advancing the catheter into the lesion, it got stuck in pre-pci.A coronary artery dissection occurred when the device was removed with the guidewire.The tip of the catheter was frayed.Additional treatment was not necessary and ivus was used to continue and complete the procedure with no adverse consequences to the patient.
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One dragonfly opstar imaging catheter was received for evaluation.The results of the investigation concluded that the guidewire exit port had been torn in an outward direction toward the distal end; however, the tip of the catheter appeared non-anomalous and as expected with no fraying.Functional testing revealed that the catheter mini-rail measured 0.0155¿, which was within manufacturing specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Although the exact cause of the reported event and reported dissection issue remains unknown, the guidewire exit port damage is consistent with the reported event.The cause of the guidewire exit port damage is consistent with damage during use.
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