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

Model Number 777F8

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned, however the evaluation is still being completed.A supplemental with the results will be sent when the evaluation is complete.The lot number was not provided; therefore a review of the manufacturing records could not be completed.

Event Description

It was reported that during use, inaccurate measurements of continuous cardiac output (cco) and right ventricular ejection fraction (rvef), and no end-diastolic volume index (edvi) value were observed.The suspect values were cco 8.1 l/min, rvef 14%, edvi no value.Rvef 55% was measured by echocardiography.The measurements did not correspond with the patients status.The issue was not resolved by replacing the cable and monitor; however, the catheter was continuously used.There was no abnormality including obstruction, leakage, or kink in the catheter.The patients information was not available.No additional medication or intervention was given based on the abnormal measurements.There was no patient injury and no complications occurred.

Manufacturer Narrative

One model 777f8 catheter with attached monoject 1.5 cc volume limited syringe, 3 three-way stopcocks and 1 tubing set was returned for examination.The reported event of the measurement issue was not able to be confirmed during evaluation.However, the catheter body had an indentation at 55.5 cm proximal from catheter tip.No fault messages showed up on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.9 c when submerged into a 37.0 c water bath.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for five minutes without error.Thermistor and thermal filament circuit were continuous; there were no open or intermittent conditions.There was no visible inconsistence observed on the eeprom data.The resistance value of thermal filament circuit was measured 37.49 ohms, which was in specification.Both thermistor and thermal filament connectors were opened and found no visible inconsistencies.No other visible damage or inconsistency was observed from the catheter body, balloon or returned syringe.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.A review of the manufacturing records indicated that the product met specifications upon release.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the 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.Show less.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12861157
• MDR Text Key: 281166408
• Report Number: 2015691-2021-06462
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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: 10/12/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63411144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1