MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 746F8

Device Problems Device Alarm System (1012); Break (1069); No Device Output (1435); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 746f8 catheter with a monoject limited volume syringe and non-edwards contamination shield.The error message "check thermal filament connection" appeared when the catheter was connected to both the lab hemosphere and vigilance ii monitors.The thermal filament circuit was in an open condition during continuity testing.Visual examination found the thermal filament cover was detached at the proximal thermal filament cover bond.At 8.3 inches proximal from the distal tip, the thermal filament cover was torn and the thermal filament trace was also broken.The thermal filament cover edges at the torn location appeared to match.The thermal filament trace edges at the break location did not match.The catheter body had an approximated 0.05inch wide cut into two non-through lumens and into the thermistor lumen, also at 8.3inches proximal from the distal tip.The thermistor was found to read 36.9°c when submerged in a 37.0°c water bath.The thermistor temperature reading was within specified accuracy, per the vigilance manual.There were no open or intermittent condition in the thermistor circuit.Cut down was performed on the thermistor connector housing and there was no visible blood leakage observed in the connector housing.The eeprom data was found to be normal.Both the stored data and the computed data matched.The catheter passed in-vitro calibration with the lab¿s cal-cup.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.All through lumens were found to be patent without any leakage.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The customer report of a cco issue was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications are well described in the literature.In this event, the thermal filament trace edges at the break location did not match.When there are missing parts from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.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.

Event Description

It was reported that during use in the icu, there was no continuous cardiac output (cco) data from the swan-ganz catheter.The nurse stated that were no issues with the catheter in the or and cco data had been displayed on the vigii monitor.After surgery was complete, the patient was transferred from the or table to the bed where the patient coded and was subsequently defibrillated 4 times.The patient coding was not related to use of the swan-ganz catheter.The patient was successfully resuscitated and was not reconnected to the vigii monitor but transferred to the cvicu where they connected the swan-ganz catheter to a hemosphere monitor.In-vivo oximetry calibration was successfully completed, and svo2 data and continuous blood temp were displayed; however, there was no cco data.An error message was displayed on the monitor: ¿fault co - check thermal filament connection¿.The error message persisted despite the following trouble shooting attempts: they ran a self-test on the cco cable and it passed.They changed the hemosphere monitor.The swan-ganz module was removed and reinserted to reset the module.The staff deduced that the thermal filament became damaged during the defibrillation attempts in the or.A new catheter was not placed.No patient harm occurred as a result of the missing data.Patient demographics were unknown.The lot number is unknown.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8861294
• MDR Text Key: 154114727
• Report Number: 2015691-2019-02900
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1