It was reported that the dragonfly optis imaging catheter was unable to connect during the procedure [no image].Therefore, the imaging catheter was removed, and another unspecified catheter was used to complete the procedure.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.Device return revealed the guidewire exit notch was torn for a length of 2mm.No additional information was provided.
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A query of the complaint handling database for the reported lot was performed and revealed no other complaints reported from this lot.Visual analysis and optical fiber testing were performed on the returned device.The reported imaging issue was unable to be confirmed due to the condition of the returned device.However, an optical fiber test was performed which revealed an optical fiber fracture at the lens which can result in the imaging issue.It was also noted that the entire length of the window tube was stretched and the guidewire exit notch was torn; however, the damage is not related to the reported imaging issue.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 similar complaint reported from this lot.Based on the similar product investigation/complaint review, there is no indication of a lot specific product quality issue.The investigation determined that the reported imaging issue was related to the circumstances of the procedure.Based on the evaluation of the returned device, the difficulty appears to be due to the noted optical fiber fracture within the lens region.It is likely that during positioning or withdrawing the device within the anatomy/heavy stenosis, inadvertent damage to the optical fiber and the window tube occurred resulting in the reported issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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