It was reported the dragonfly optis imaging catheter was to be used in the left anterior descending (lad) lesion with moderate stenosis, moderate tortuosity, and severe calcification for pre-percutaneous coronary intervention (pci).However, resistance was felt with the lesion during advancement and the imaging catheter failed to cross the target lesion.The imaging catheter was removed and the tip was noted to be frayed.Therefore, an unknown catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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 identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported failure to advance and material frayed.It may be possible that adverse patient anatomical morphology affected the maneuverability of the device.Furthermore, after the device failed to cross the lesion, the device may have been damaged.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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