One bipolar pacing catheter with attached monoject 1.3 cc volume limited syringe was returned for evaluation.A non-edwards contamination shield was located between 13.5 cm and 62 cm from the catheter tip.Continuity testing found that a short condition occurred around the catheter tip.Catheter cut down revealed that lead wires were not insulated between 5.4 cm and 5.7 cm from the catheter tip.This condition allows to make contact with both wires and cause short condition.After separating both wires, continuity testing found that there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.No visible damage was observed from the catheter body, balloon, windings, or returned syringe.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.A review of the manufacturing records indicated that the product met specification at the time of release.Customer report of pacing 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.
|