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

Model Number 777F8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and a three-way stopcock were returned for evaluation.A non-edwards contamination shield was located on the catheter between 56.5 cm and 100 cm proximal from the catheter tip.No packaging or introducer was returned.Without the return of the pressure monitoring unit the customer report could not be confirmed.Attached non-edwards contamination shield was removed for evaluation.All through lumens were patent without any leakage or occlusion.The thermistor was found to read 37.0 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 the thermal filament circuit was within specification, measuring 40.17 ohms.Both the thermistor and thermal filament connectors were opened and no visible inconsistencies were found.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage or inconsistency to the catheter body, balloon, or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Balloon inflation testing was performed using returned syringe with 1.5 cc air.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Without the return of the pressure monitoring unit, customer report of pressure issue could not be confirmed.The device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.It is unknown if any clinical or procedural factors may have contributed to this event.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

It was reported that the pulmonary artery pressure (pap) was higher than expected.The obtained value was 30mmhg but the expected value was 10mmhg.The catheter was replaced and the problem was solved.The patient was not treated on the perceived inaccurate values.An error message was not observed.There were no patient complications reported.Inquired of patient demographics.Unable to be obtained.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• 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: 6191901
• MDR Text Key: 62914416
• Report Number: 2015691-2016-03838
• 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: Physician
• Type of Report: Initial
• Report Date: 12/09/2016

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 Expiration Date: 08/29/2018
• Device Model Number: 777F8
• Device Lot Number: 60562698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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