Visual and functional analysis was performed on the returned device.The reported failure to equalize was not confirmed.The returned unit was functionally tested in a coronary artery simulator and was able to calibrate and equalize within the specifications for the pressurewire.There was unknown material inside the returned packaging coil dispenser measuring 1 cm.The returned pressurewire had no missing segment.It was determined that the unknown material was not part of the pressurewire.It is likely the material got inside the packaging col dispenser accidentally during post-procedure handling.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 pressure registration issue.It may be possible that procedural contaminants/contrast on the pressure sensor membrane or a system issue occurred contributing to the reported pressure registration issue; however, 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.
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