MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO V; SWAN GANZ CATHETER

Model Number	777F8
Medical Device Problem Codes	Incorrect Measurement (1383); Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient use in the cvicu, using a swan ganz catheter, there were erratic patient measurements of the core temperature, while connected to the hemosphere monitor.The issue would temporarily resolve if the cco cable was unplugged from the catheter and then plugged back in.However, the temperature would begin drifting to abnormally high values.Reported as high as 115 degrees f, leading to the cessation of cco readings.The clinicians reportedly ran a successful cco cable test on the cable involved.The issue still occurred when using a replacement cable as well.The catheter had reportedly been indwelling for three days prior to this issue.A new catheter was not inserted.The exact event date is unknown.The catheter was not saved for return.There was no inappropriate patient treatment reported.The patient demographics have not been provided.There was no patient harm or injury.
Additional Manufacturer Narrative
The product was discarded and is not available for return and product evaluation.The device history record review is pending.When the results are available a supplemental submission will be sent with the information.
Additional Manufacturer Narrative
It was previously reported in error that the product was discarded and unable to be evaluated.Our product evaluation lab received one model 777f8 catheter with a non edwards contamination shield.When connected to the lab hemosphere monitor, no fault readings were noted.The thermistor read 37.0 degrees celsius when submerged in a 37.0 degrees celsius water bath.The thermistor reading was within specified accuracy, per the hemosphere manual.The catheter ran continuous cardiac output in a 37.0 degrees celsius water bath for 5 minutes with no error.The thermistor and thermal filament circuits were continuous with no open or intermittent conditions.No visible inconsistencies were observed on eeprom data.The resistance value of the thermal filament circuit was measured within specification at 37.07ohms.Both the thermistor and thermal filament connectors were opened, and no visible inconsistencies were found.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric, and remained inflated for more than 5 minutes without leakage.No damage or inconsistency was observed from the catheter body, balloon, or the returned syringe.The customer report of erratic measurements of core temperature and no cardiac output reading were unable to be confirmed on evaluation.A device history record review and an engineering evaluation have been ordered to assess for any manufacturing-related processes which could be correlated to the complaint.A supplemental report will be sent with the investigation results, as indicated.

• Brand Name: SWAN GANZ CCOMBO V
• Common Device Name: SWAN GANZ CATHETER
• 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 ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15008825
• Report Number: 2015691-2022-06764
• Device Sequence Number: 11342083
• Product Code: DQE
• UDI-Device Identifier: 00690103003031
• UDI-Public: (01)00690103003031(17)230723(11)210723(10)63881296
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K040287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 831F75P
• Device Lot Number: 63881296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown