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

Model Number 746F8

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review has been initiated and upon completion, a supplemental report will be sent with the results.Udi #(b)(4).

Event Description

It was reported that during use of a model 746f8 swan-ganz catheter with a postop cardiac patient who had undergone cabg, the cardiac index and strove volume were inaccurate on the hemosphere monitor.The patient was not on an inotrope, had an ejection fraction (ef) of 60-65%, and was v-paced.The mean arterial pressure (map) was displaying in the 80's, pulmonary artery pressure (pap) was in the range of 40/25, central venous pressure (cvp) was 14-18, and the svo2 ranged in the 70's.The problem they saw was that the cardiac index (ci) value was between 1.4-1.8 with a stroke volume (sv) in the 30's despite volume boluses.It was noted that while the volume was going in, they saw changes in cvp but no change in sv.The patient had good pulses and good urine output.The patient received fluid boluses as a result of the inaccurate ci values but there was no apparent patient harm, as the clinicians recognized the issue early.Patient demographics were requested and not provided.It was noted that the anesthesiologist had mentioned that "the swan never worked for us in the or".They did not do anything to troubleshoot the svo2 machine since there were also issues in the or and there were no error messages.

Manufacturer Narrative

Our product evaluation laboratory received one model 746f8 catheter with a monoject limited volume syringe and a non-edwards contamination shield.When connected to the lab hemosphere monitor, no fault messages showed up.The thermistor read 37.1°c when submerged into a 37.1°c water bath.The thermistor temperature reading was within specified accuracy, per the hemosphere manual.The catheter ran cco in a 37.1°c water bath for 5 timed minutes with no error.The thermistor and thermal filament circuits were continuous, and there were no open or intermittent conditions.The eeprom data was found to be normal.Both the stored data and the computed data matched.The resistance value of the thermal filament circuit was measured at 36.79 ohms, which was in specification.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for more than 5 timed minutes without leakage.No visible damage was observed from the catheter body.The catheter passed in-vitro calibration with the lab cal-cup.The catheter also passed the attenuation test.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a cardiac output issue was not confirmed on evaluation, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance; however, 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.With any hemodynamic monitoring, hemodynamic 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 regard 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.Hemodynamic values and pressure readings should correlate with the patient¿s 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

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 00610
• MDR Report Key: 8932592
• MDR Text Key: 196457262
• Report Number: 2015691-2019-03186
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 62248784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1