It was reported that during the preparation, bubbles were observed around the proximal end of the the dragonfly optis imaging catheter; therefore, an air leak was suspected.The catheter was not use in the patient and the procedure was completed with a new dragonfly optis imaging catheter.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Visual inspection was performed on the returned device.The reported gas leak was unable to be confirmed as the device could not be purged due to dried contrast.During visual analysis, there were no damages noted to the device.The cap and the syringe were not returned.The device remained in an ultrasonic bath for three days to remove the contrast; however, the contrast could not be removed.An unrelated optical fiber fracture was found near the lens region.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 received and analysis of the returned device, the investigation was not able to determine a definitive cause for the reported leak.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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