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 indication of a lot specific product quality issue.Based on the information provided, the reported difficulty appears to be due to circumstances of the procedure.It is likely that the reported damage/kinks to the guide wire caused resistance while attempting to remove the dragonfly from the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported this was a procedure to treat a moderately calcified and moderately tortuous right coronary artery.A dragonfly opstar catheter was inserted without issues.However, during removal of the catheter resistance with the guide wire was felt.The physician stopped the independent removal of the catheter and decided to remove the non-abbott guide wire and catheter simultaneously.Upon removal, the non-abbott guide wire was noted to be kinked.A new dragonfly catheter was inserted for the post run and no issues occurred.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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