It was reported that 'unstable cco value was observed during use. It is unknown what the readings were or if there were any error messages observed. There was no damage noted on the catheter. ' the sample of tracing was not available. There were no patient complications reported.

One catheter was returned with monoject 1. 5cc limited volume syringe for evaluation. No introducer or contamination shield was returned. The thermistor read 37. 0 c when submerged into a 37. 0 c water bath. The catheter was connected to the vigilance i monitor and vigilance ii monitor and 'check thermal filament position' error message was shown on both monitors. According to the operator's manual for the vigilance ii monitor, possible causes for the 'check thermal filament position' message are the following: 'flow around thermal filament may be reduced. Thermal filament may be against vessel wall. Catheter not in patient. ' these error messages can be expected during testing in a static water bath. Thermistor and thermal filament circuit were continuous; there were no open or intermittent conditions. No visible inconsistencies were observed on eeprom data. Both thermistor and thermal filament connectors were opened and found no visible inconsistencies. Resistance value of the thermal filament circuit was measured at 37. 66 ohms, which is within specifications. All through lumens were patent without leakage or occlusion. The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage. No visible damage to the catheter body or returned syringe was observed. The lot number was not provided; therefore, a review of the manufacturing records could not be completed. Visual examinations were performed under 10x magnification. This type of report has been confirmed as related to the manufacturing process. An investigation is underway to determine what actions are needed to prevent recurrence of this type of complaint.

At the initial investigation of the complaint, this was considered an isolated event. A deeper investigation identified a larger issue and corrective actions were implemented. In addition, an awareness training was given to the manufacturing personnel.