Subsequent to the initial report, the following information was provided: it was reported the dragonfly opstar imaging catheter was to be used in the distal right coroany artery (drca).However, the tip of optical coherence tomography (oct) catheter broke off into two pieces during the procedure and had to be removed with a balloon.The procedure completed using angiographic guidance.No additional information was provided.
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The device was not returned for analysis.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 did not indicate a lot specific quality issue.Based on the information provided, a definitive cause for the reported material separation could not be determined.It may be possible that the dragonfly was inadvertently damaged due to repeated interaction with challenging anatomical morphology.However, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem: updated e1: first, last name and title updated.E3: occupation updated.G2: report source updated.
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