It was reported that the device was leaking.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure in the superficial femoral artery.The jetstream xc catheter had made three passes in the stenosed area of the artery and successfully completed atherectomy.The physician was removing the catheter out of the patient using rex mode, when it was observed that blood was leaking out of the plastic tubing near the console.This leak was not observed at the beginning of the procedure.An error message indicating "bubble detected" also appeared.The physician then manually backed the jetstream xc catheter off of the guidewire and the procedure was successfully completed with no patient complications reported.Device evaluated by mfr: visual examination showed no damage on the catheter shaft or roller pump tubing for the infusion line.Visual examination of the aspiration tubing showed a cut/hole in the tubing.With this damage leakage would be present.The damage is consistent with the incorrect insertion of the aspiration tubing into the roller pump at the start of the procedure.With the tubing not inserted fully and the door shut this would cause a pinch point against the tubing and cause the cut/hole that was noticed.The device could not be set-up and functionally tested due to the leak may cause console damage in the form of fluid flowing into the mechanical components.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
|