Dragonfly OpStar¿

Description of Event or Problem

It was reported that the procedure was performed in the left anterior descending (LAD) artery with sharp-angle 90 degree tortuosity. The Dragonfly Opstar imaging catheter was not able to connect even after multiple attempts. Another Dragonfly Opstar imaging catheter was successfully calibrated and equalized; however, image was distorted. The procedure was completed with angiograms only. There was no adverse patient effect and although there was prolonged time in the procedure, the delay was not clinically significant as there was no patient harm. Returned device analysis identified the guidewire exit notch was torn and extended distally into the minirail for a length of 1.5 mm (millimeters). No additional information was provided.

Additional Manufacturer Narrative

A visual inspection and additional testing methods were performed on the returned device, and review of the submitted media (videos) was performed. The reported poor imaging results were able to be confirmed. Production record and Corrective and Preventative Actions (CAPA) reviews were performed and revealed no indication of a product quality issue. Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue. Based on the reported information, the user-submitted media (videos), and the observations from the returned analysis, the investigation determined that the reported poor imaging results appear to be related to circumstances of the procedure. The catheter was returned with an optical fiber break, which likely contributed to the reported poor imaging results; however, there was blood noted in and around the imaging catheter¿s lumen during both pullback videos, as well as stitch-up imaging artifacts¿which can cause or contribute to the observed imaging artifacts (stitch-up). In this case, it is likely that a combination of the broken optical fiber and the blood observed in the pullback frame which caused the poor imaging results (stitch-up). The guidewire exit notch was noted to be torn, which is consistent with being inserted onto and forcefully removed from a guidewire, or from post-procedure handling/wiping, and is not related to the reported event. Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.