One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.Continuity testing found that the distal lead wire had an intermittent condition around the electrode, when flexing the tip area of the catheter.Proximal circuit was continuous without any intermittent or open condition.No short condition was observed between the proximal and distal lead wires.A cut down was performed to isolate the intermittent condition and the intermittent condition was found to be at distal lead wire tip.The balloon inflated but failed to maintain its inflation due to leakage from a gap around circumference between proximal electrode and catheter body.The leakage is due to an adhesive separation from under the proximal electrode.No visible damage was observed from windings, balloon or returned syringe.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of pacing issue was confirmed.Additionally, a balloon inflation issue was also confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
|