It was reported the procedure was performed in the mid circumflex.It was noted the patient had mitral valve stenosis.During preparation of the dragonfly imaging catheter, it was observed that contrast was continuously flowing out of the device, rather than dripping.Although this was observed, the physician decided to continue the procedure without replacing the device.The catheter was inserted and advanced to the target lesion.However, the patient had a coronary spasm with an st elevation, followed by shock.The physician was unable to determine if the catheter caused or contributed to these patient effects.An error message then occurred stating the catheter needed to be disconnected.Therefore the device was removed.There was no clinically significant delay in the procedure.No additional information was provided.
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Visual and dimensional analysis was performed on the returned device.The reported connection issue was unable to be confirmed due to the condition of the returned device.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 reported patient effect of coronary artery spasm is listed in the dragonfly optis instruction for use as a known complication that may occur as consequence of intravascular imaging and catherization procedures.In this case, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information received and analysis of the returned device, the investigation was not able to determine a definitive cause for the reported communication or transmission problem or device difficult to set up or prepare.It may be possible that, during device use, the internal optical fiber was inadvertently damaged causing the reported communication or transmission problem.However, this could not be confirmed to the returned condition of the device.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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