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

Model Number 777F8

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model 777f8 swan ganz catheter with attached monoject 1.5cc volume limited syringe, x3ea three way stopcocks and a non ew contamination shield located 26.5cm to 95.5cm proximal from the tip.When connected to the lab hemosphere monitor, no fault messages were displayed.The thermistor was found to read 37.0 degrees celsius when submerged into a 37.1 degree celsius water bath, which was within specification per the hemosphere manual.The catheter ran cco in a 37.0 degree celsius water bath on the hemosphere monitor for 5 timed minutes without error.The thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistency was observed on eeprom data.The resistance value of the thermal filament circuit was measured 39.15ohms, which was in specification.Both the thermistor and thermal filament connectors were opened, and no visible inconsistencies were found.No visible damage or inconsistency was observed from the catheter body, balloon and the returned syringe.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.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a cco measurement issue was not able to be confirmed during evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that continuous cardiac output, aka cco, and continuous cardiac index, aka cci, values were higher than expected during use in the icu.The indicated cco was higher than 10l/min, whereas the expected value was 7l/min.The indicated cci was higher than 7l/min/m2.No error message was displayed on the monitor.The catheter tip was repositioned, but the issue persisted.The patient was not treated based on the incorrect value.A sample tracing was unavailable.It was noted that the patient heart rate was normal.The catheter was not replaced.Information such as if there was occlusion, leakage or kink noted in the catheter or if the value was affected by the patient condition is unknown.No malfunctions of the monitor or cable were suspected.The patient demographic information was requested but unavailable.There were no patient complications reported.The date of the event is also unknown.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V
• 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 ; 9492500294
• MDR Report Key: 16689974
• MDR Text Key: 312790837
• Report Number: 2015691-2023-12131
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240120(11)220120(10)64200102
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64200102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2022
• 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