It was reported that during the procedure, the pressurewire x wireless (pwx) had an abnormal equalization value.The atrial pressure had an equalization difference of 35 on the first try, and 63 on second attempt.After the pwx was removed, the tip was noted to be frayed.Another pwx was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.The issue occurred in lab 3.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 was unable to determine a cause for the reported faulty pressure registration and frayed tip coil.It may be possible that during insertion or removal, the tip coil was caught by accessory devices (such as an introducer needle, etc) or another catheter which could result in the reported frayed tip coil.It may also be possible that the wire was inadvertently damaged such as bend/kink which may cause an electrical issue and affect the reading resulting in the reported pressure registration issue.However, without having the device examined, these 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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