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

Model Number 774F75

Device Problems Display or Visual Feedback Problem (1184); Incorrect Measurement (1383); Increase in Pressure (1491)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product 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 during the insertion of a swan-ganz catheter, the hemodynamic pressure displayed too high.It was not known if an error message or alarm was displayed.It is not known what the expected values were based on the patient status at the time of the event.It is also not known if the patient was treated according to the displayed value.The issue persisted after re-zeroing the device, so a new swan-ganz was placed and the issue was resolved.There was no allegation of patient injury.No further information was available, including the lot number and patient demographics.

Manufacturer Narrative

One catheter was returned for evaluation.Customer report of "hemodynamic pressure showed too high" could not be confirmed during evaluation.Per pressure monitoring ifu, "poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks".All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from the catheter body, connectors or balloon.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No fault messages appeared 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 37.50 ohms.Catheter passed in-vitro calibration on vigilance ii monitor.Balloon testing was performed with returned syringe.Visual examination was performed under microscope at 10-200x magnification and with the unaided eyes.The lot number was obtained and a device history record review was completed and documented that the device met all specifications upon distribution.Customer report of pressure readings issue could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient¿s clinical manifestations.In this case it is unknown whether any user or procedural factors may have contributed to the stated event.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9598329
• MDR Text Key: 188655012
• Report Number: 2015691-2020-10216
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 62199498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1