It was reported the two dragonfly optis imaging catheters (9059464 and 8204330) were to be used in the left anterior descending (lad) lesion.However, the imaging catheters displayed an error "connection failure (395).The imaging catheter could not be connected" message displayed prior to calibration; therefore, the imaging catheters were removed and the procedure completed without using oct.It was noted that the second imaging catheter (8204330) was used after the expiration date.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Visual analysis and additional testing were performed on the returned device.The reported calibration issue was not able to be confirmed due to the returned condition of the device (dried contrast within sheath) which prevented functional testing.The investigation was not able to determine the cause for the reported calibration issue.The optical fiber of the returned catheter was verified to be intact.Further, there were two successful pullbacks recorded on the returned device--suggesting two successful calibrations took place prior to the pullback activation.There was a kink observed to the catheter; however, this was determined to be unrelated to the reported event.It was determined that the returned dragonfly optis was used after expiration.The event date was (b)(6) 2023 and it was determined that the device expiration date was (b)(6) 2023.Therefore, the device was used approximately 3 weeks after the labelled product expiration date.The expiration date of the product is important for the sterility, efficacy, and performance of the device.The dragonfly optis instruction for use (ifu) 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.
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