Additional information: the device was removed through the sheath without any intervention required.Evaluation summary: the protégé rx unit was returned.No ancillary devices were included.The protégé rx was inspected and the distal end of the stent was found to be flowered out from the distal rim of the blue outer.The tuohy-borst valve was tightened.The distal tip and guidewire lumen were exposed outside from the distal tip of the catheter about 0.5cm.A bend to the catheter was observed at approximately 21 cm from the distal tip.No damage to the stent was observed.A guidewire from the lab was attempted to be loaded; however the lumen was occluded so the guidewire could not pass.The protégé rx was inserted into the lab deployment apparatus.After loosening the tuohy-borst valve the stent would not deploy at 2.58 lbs.The hypotube between the tuohy-borst valve and deployment grip showed bending while pressure was applied.The catheter was removed from the deployment apparatus and attempts to push the deployment grip were carried out.The deployment grip, advanced against resistance, was able to deploy the stent.No damage to the stent was observed.Within the blue catheter inner diameter, traces of dried blood was noted.If information is provided in the future, a supplemental report will be issued.
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