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 identified no indication of a lot specific product quality issue.Based on the information provided, the reported difficulties appear to be due to operational context.It is likely that the patient¿s anatomical condition, as well as the condition of the guidewire being used (kinks/bends), caused the difficulty while attempting to remove the catheter; however, this could not be confirmed.The reported imaging issue could be due to the catheter¿s optical fiber being damaged during insertion/use; however, this could also not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the patient presented with st elevation myocardial infarction with thrombus in the left anterior descending (lad) artery.A non-abbott thrombectomy device was used to remove the thrombus and pre-dilatation was performed using a 2.5 x 30 mm trek neo dilatation catheter.The dragonfly optis imaging catheter was loaded onto the non-abbott guide wire.Difficulty was noted during advancement and the dragonfly optis became stuck on the wire.It was thought that there was contrast on the guide wire and the guide wire was wiped down; however, the resistance continued.During removal from the guide wire, the dragonfly optis catheter stretched and the live image on the screen was lost.A message was displayed "fiber broke.Remove catheter from the doc".The dragonfly optis was able to be removed from the guide wire.One additional attempt was made to reconnect, but no image was displayed.There was no adverse patient effect and no clinically significant delay.A second dragonfly optis was used with the same guide wire.No additional information was provided.
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