One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.A non-edwards 5fr introducer was located between 41.5 cm and 55 cm from the catheter tip.Blood was visible inside the balloon.As received, catheter tip was slightly bent.Continuity testing was performed on the distal and proximal circuits and no open, intermittent, or short conditions were observed.The balloon inflated but failed to maintain its inflation due to leakage from a gap around the circumference between proximal electrode and catheter body.The leakage is due to an adhesive separation, and leakage is from under the proximal electrode.No visible damage to the balloon, windings or returned syringe was observed.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 could not be confirmed during the analysis, however, balloon inflation issue was 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.
|