MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774F75

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that after an open-heart surgery procedure with a swan-ganz catheter, the svo2 worked but the continues cardiac output never gave a number greater than 0.2 and gave a fault message of ¿blood temp¿ fault.The patient did not have sequential pressure stockings on, and the cable was changed without a correction to the cco.The catheter was replaced, and it started to work with a good cco.No patient complications were reported but the patient had to have a new stick for a new catheter.

Manufacturer Narrative

One 774f75 with monoject limited volume syringe and a non-edwards contamination shield were returned for examination.The reported event of cco issue was not confirmed.No fault messages showed up on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 37.0 °c when submerged into a 37.0 °c water bath.The thermistor temperature reading accuracy is +/- 0.3 °c per the vigilance ii manual.The catheter ran cco in 37.0 °c water bath on vigilance ii monitor for 5 minutes with no error.The thermistor and thermal filament circuits were continuous, there were no open or intermittent conditions.No visible inconsistencies were observed on the eeprom data.The resistance value of thermal filament circuit was measured and found to be with in specification.Both the thermistor and thermal filament connectors were opened and found no visible inconsistencies.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage was observed from the catheter body or returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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.An unstable baseline temperature tracing can be an indication to the user to begin the troubleshooting process before a cardiac output measurement is attempted.The patient¿s body temperature can be obtained by different means and compared to the temperature obtained from the catheter.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort the attempt to obtain cardiac output.The catheter can be exchanged if desired.In this case, the patient required a new stick to insert a new catheter.It is unknown if user or procedural factors may have contributed to this 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.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 11139783
• MDR Text Key: 227072738
• Report Number: 2015691-2021-00045
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 62333964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1