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

Model Number 746F8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

One 746f8 catheter with two edwards dpts attached to distal lumen and proximal injectate lumen were returned for examination.The reported event of "temperature was fluctuating" was not confirmed during the evaluation.The catheter was submerged in a 36.9°c water bath and read 36.9°c on the vigilance ii monitor.Thermistor temperature reading accuracy is +/- 0.3°c per the vigilance ii manual.The eeprom data was found to be normal and both the stored data and the computed data matched.A cut down was performed on the thermal filament and thermistor connectors and there was no visible abnormality on the thermal filament connector.However, the insulation of the thermistor leadwire connecting to the rc pin was partially peeled off and the leadwire was exposed.The exposed leadwire would create a short condition in the thermistor circuit when contacted the rt pin.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No visible damage was observed from the catheter body.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A supplemental report will be forthcoming with the device history results when received.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 is well described in the literature.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this event a new stick was required for the insertion of a new catheter.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 of a model 746f8 swan, the blood temperature was fluctuating between 32-38 degrees celsius, which was not correct.When the temperature was at 32 degrees celsius for any length of time, the monitor would display an error message stating that the temperature was outside of parameters, and all of the numbers would disappear.Troubleshooting was performed on the cables over the phone with edwards lifesciences and the monitor and the cables were switched out.Once troubleshooting was done on the new cables, the error happened less frequently but still happened.A day or two afterward they chose to hook up a flotrac and then ended up floating another swan after that.Per the user, if they had not had to pull the swan with the original issues, it would likely have stayed in all that time.There was no allegation of patient injury.The exact date of occurrence is unknown.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.Udi # (b)(4).

Manufacturer Narrative

Corrected data: f10, h6.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
• MDR Report Key: 9434216
• MDR Text Key: 189488962
• Report Number: 2015691-2019-04524
• 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
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2021
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 62311786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1