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

Model Number 774F75

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.A device history record review has been initiated to document that the device met all specifications upon distribution.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 inaccurate svo2 values and continuous cardiac output measurement issues were observed during use of 774f75 swan-ganz catheter.The displayed svo2 value on a hemosphere was approximately 20 percent lower than the customer expected.The patient was not treated on the incorrect value since the value was considered unreliable.No error message regarding inaccurate svo2 value was observed.Svo2 value from the blood sample was 50 percent and in vivo calibration was performed with this value.However, after the calibration was performed, the indicated svo2 was 30 percent.The physician thought it was unreasonable that the values varied from by 20 percent in such a short period of time.There was no large time gap between blood sampling and calibration.The patient had a medical history of myocardial infarction and was suspected to have dilated cardiomyopathy, however, there was no factor that the value dropped from 50 percent to 30 percent.The catheter was not replaced.The hemosphere monitor was replaced with a vigilance ii monitor and the cable was replaced but the issue persisted, therefore, the malfunction of the catheter was suspected.As for cco measurement issue, the error message of check thermistor was observed on the hemosphere monitor and cco could not be measured.The 70cc2 cable was replaced, but the issue persisted.The displayed rectal temperature was 37 degrees celsius.The catheter has not been replaced since it is used to monitor the pulmonary artery pressure without cco or svo2 values.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received 774f75 catheter with attached monoject 1.5 cc limited volume syringe, 1 pressure tubing set, 1 three-way stopcock and non-ew contamination shield which located 46.5 cm to 108 cm proximal from the tip.No package or cal-cup was returned with the catheter.Hemosphere monitor showed error message check thermistor connection when connecting the monitor to returned catheter.Both thermistor and thermal filament connectors were opened with no visible inconsistencies.Resistance value of thermal filament circuit was measured 40.10 ohms, which was in specification.No visible inconsistence was observed on eeprom data.The catheter passed in-vitro calibration on hemosphere monitor.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.Distal thermal filament cover bonding site was torn.The torn edges matched up.No other visible damage was observed from catheter body, balloon, and returned syringe.The customer report of cco measurement issue was confirmed.Customer report of svo2 measurement issue was unable to confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A supplemental report will be submitted if there are any findings.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.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16637468
• MDR Text Key: 312361247
• Report Number: 2015691-2023-11942
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146998
• UDI-Public: (01)00690103146998(17)240921(11)220922(10)64598505
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 64598505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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