It was reported that the pressurewire x, wireless device was intended to be used in the left circumflex artery (lcx) lesion.However, there was resistance felt while advancing the device and failed to cross the lesion due to the anatomy.Therefore, the device was removed from the patient.It was noted that resistance was also felt upon removal of the device.The procedure was completed with another unspecified device.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 indication of a lot specific product quality issue.The investigation determined the likely cause for the reported failure to advance and difficulty removing the catheter was operational context.It is likely that during the attempt to cross the lesion, while pushing against resistance, the pressurewire guidewire became damaged (kinked/bent) resulting in resistance/difficulty during advancement¿ultimately causing the failure to advance and the subsequent removal difficulty; 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.Na.
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