Visual analysis, functional analysis, and optical fiber testing were performed on the returned device.The reported connection issue was not confirmed.The catheter was connected to the doc successfully.The catheter was able to connect and proceed to live-view mode.An optical fiber test was performed, which revealed the optical fiber remained intact.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 revealed no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported connection issue as the returned unit functioned as intended.Additionally, scan of the rfid read that there had been 3 load counts and 5 pullbacks performed at the account which contradicts the reported information that the imaging catheter failed to connect.The dragonfly optis instruction for use lists a ¿use by¿ icon which indicates that the device is to be used prior to the expiration date on the product label.It could not be determined if using the device after the expiration date contributed to the difficulties and the returned device analysis found no issues with the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: device code 2017 clarifier- use after expirationna.
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It was reported that during the procedure, the dragonfly optis imaging catheter was intended to be used in the left anterior descending artery (lad) with moderate calcification and heavy tortuosity.However, after the imaging catheter crossed the lesion the imaging catheter failed to connect, cal-002 error code displayed.Therefore, the imaging catheter was removed from the patient, and the procedure was completed with another dragonfly optis imaging catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.It was noted the device was used past the expiration date.
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