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

Model Number 777HF8J

Device Problem Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and three non-edwards plugs were returned for evaluation.An arrow introducer with non-edwards contamination shield was located on the catheter body between 37.5 cm and 91 cm proximal from the catheter tip.No packaging was returned.No fault messages were observed on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.9 c when submerged into a 37.0 c water bath.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for 5 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.Resistance value of thermal filament circuit was within specification, measuring 39.52 ohms.Both the thermistor and thermal filament connectors were opened and no visible inconsistencies were found.No visible damage to the catheter body, balloon, or returned syringe was observed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The complaint could not be confirmed.No evidence of a manufacturing nonconformance was noted.It could not be determined if procedural factors or device handling may have contributed to the reported event.No actions will be taken at this time.

Event Description

It was reported that the swan ganz catheter was placed in the patient after cardiac surgery.After two to three days of use, cci value gradually decreased from about 2.5l/min/m2 to 1.5l/min/m2.The expected cci value was more than 2.5l/min/m2.The catheter position was checked and the catheter was in the correct position.The patient was not treated based on the incorrect value.Error message was not observed.Vig2 monitor and the cable were tested by the customer but there were no problems observed.No further information was able to be obtained.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI
• Type of Device: 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5638601
• MDR Text Key: 45313624
• Report Number: 2015691-2016-01525
• Device Sequence Number: 1
• Product Code: DQE
• 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: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777HF8J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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