The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number provided was reported as a possible lot number; lot 62604570 (manufactured date: 06-oct-2019 , expiration date: 01-oct-2021 ).A device history record review was completed for the lot and documented that the device met all specifications upon distribution.
|
One bipolar pacing catheter without any attached components was returned for evaluation.As received, catheter tip was slightly bent.Continuity testing confirmed a short condition occurred around the catheter tip.Catheter cut down revealed that the distal lead wire was not insulated between 1.7 cm and 2.2 cm from the catheter tip which allowed contact with the proximal lead wire causing the short condition.After separating both wires, continuous condition was confirmed between the distal electrode and proximal connector pin and between the proximal electrode and distal connector pin.The electrode connectors were assembled correctly to the y-adapter.The balloon inflated clear and concentric and remained inflated for 5minutes without leakage.No visible damage from the catheter body, balloon, windings, or returned syringe was observed.Balloon inflation test was performed using lab 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 during the analysis.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.
|