MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Model Number 831F75

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/12/2021

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.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that the svr, core temp and cardiac index values were inaccurate on both (b)(6) 2021.On (b)(6), the ci was 1.0 and the core temp was 33.5.On (b)(6) , the ci was 1.27 and the core temp was 35.The patient was moved to the icu and re-warmed but was getting a temp of 37 with the svr over 5000.The mixed venous blood draws on the patient did not correlate with the readings.However, the pa pressures and waveforms appeared normal.Trouble shooting included changing of the cables, but the inaccurate values persisted.The patient was ultimately placed on a dobutamine infusion.No patient complications were reported.Patient demographics were unable to be obtained at this time.

Manufacturer Narrative

One 831f75 with a monoject limited volume syringe, non-edwards contamination shield and a non-edwards manifold was returned for examination.The reported event of temperature issue was not confirmed.The catheter was submerged in a 37.0c water bath and read 37.0c on a vigilance ii monitor.The thermistor temperature reading accuracy is +/- 0.3c per the vigilance ii manual.The thermistor circuit was continuous.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without leakage or occlusion.The catheter passed the pressure test with lab disposable pressure transducer.A cut down was performed on thermistor connector and there was no visible abnormality.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.However, 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.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patients clinical manifestations.It is unknown whether user or procedural factors contributed to the stated 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.

Manufacturer Narrative

This follow-up report is a correction to the previous report in which the selection for adverse event in b1 was not populated.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) 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: 11772766
• MDR Text Key: 249092392
• Report Number: 2015691-2021-02787
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2022
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Device Lot Number: 63421541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention