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 Problems Device Alarm System (1012); Kinked (1339)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the cco value was 12.0l/min during use.The expected cco value was 2.0l/min.It was also reported that it was unable to measure pulmonary artery wedge pressure (pawp) during use but pulmonary artery pressure (pap) was able to measure properly.The catheter was not replaced and the clinician continued to use the catheter for drug administration.After the catheter was removed from the patient, a kink was noted on the catheter near the thermistor.Error message was not indicated on the monitor.Troubleshooting was not performed.The value was not affected by the patient condition.The patient was not treated based on the incorrect values.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards introducer with non-edwards contamination shield was located on the catheter body between 36 cm and 90 cm proximal from the catheter tip.No packaging was returned.Customer report of cco measurement issue was not confirmed.Customer report of pressure measurement issue was not able to be confirmed during evaluation.Without the return of the pressure monitoring unit, customer report of pressure issue could not be confirmed.All through lumens were patent without any leakage or occlusion.No fault messages were observed on the lab vigilance ii monitor when the catheter was connected.The thermistor was submerged in a 37.0 c water bath and read 37.0 c on vigilance ii monitor.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 39.15 ohms.Both the thermistor and thermal filament connectors were opened and no visible inconsistencies were found.No kink to the catheter body was observed, however, an indentation at 5.5 cm proximal from the catheter tip was observed as noted by the customer.No visible damage to the balloon or returned syringe was observed.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.An investigation has been initiated, regarding the indentation on the catheter body, to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• 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 ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5564138
• MDR Text Key: 42944912
• Report Number: 2015691-2016-01147
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

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
• Device Operator: Health Professional
• Device Model Number: 777HF8J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• 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