It was reported this was a procedure to treat a left anterior descending st-elevated myocardial infarction (stemi).A dragonfly opstar catheter was inserted and advanced; however, prior to injecting contrast, the automatic pullback was triggered prematurely.The catheter was attempted to be removed but was caught on the guidewire.Therefore, both devices were removed together.A new dragonfly opstar catheter was inserted.Again, a premature pullback occurred.This time the catheter was able to be removed without issues.There were no adverse patient effects and no clinically significant delay during the procedure.The physician admitted he was advancing the dragonfly's in live mode.No additional information was provided.
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Visual and dimensional analysis was performed on the returned device.The reported difficulty removing was unable to be confirmed due to the device condition.Damage to the dragonfly catheter was confirmed which is consistent with the occurrence of withdrawal difficulty.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 complaints reported from this lot.In this event, it was reported that catheter was advanced or positioned while in ¿live-view¿ mode.The instruction for use (ifu) for opstar imaging catheter caution the user to ¿ensure that the dragonfly imaging catheter is not rotating while the sterile operator is loading, inserting, or positioning the catheter¿.In this case, the catheter being in ¿live-view¿ denotes that the catheter was rotating, and the user is already aware of the error made.The investigation determined that the difficulties were likely related to circumstances of the procedure.The observed guidewire exit port damage is consistent with, and likely from, force applied by the physician/user during attempted removal of the catheter, or from the separation of the catheter from the guidewire after both were removed from the patient¿s anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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