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

Model Number 774F75

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)

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

Event Date 11/11/2019

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.A device history record review was completed and documented that the device met all specifications upon distribution.

Event Description

It was reported that during the insertion of a swan-ganz catheter, the hemodynamic pressure displayed too high.No error message or alarm was displayed.The issue persisted after re-zeroing the device.It was not known what the expected values were based on the patient status at the time of the event.It was also not known if the patient was treated according to the displayed value.The issue was solved by replacing the device.It was noted that the pulmonary artery pressure (pap) displayed by the second device was approximately 12-13 mmhg and remained the same after re-zeroing.There was no allegation of patient injury.Patient demographics were requested and are unknown.

Manufacturer Narrative

One catheter with 1.5cc monoject syringe was returned for evaluation.Customer report of pressure readings issue could not be confirmed.Per pressure monitoring ifu doc-0070772 rev.A, "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".Despite during decontamination process all through lumens were free of occlusion, when evaluating the sample the distal lumen was found to be occluded.A lab guidewire was used, to push out a blockage of what appeared to be dry clotted blood from the distal lumen.Thereafter, 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 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 37.60 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.Customer report of pressure readings issue could not be confirmed during the analysis, as the device responded appropriately during functional testing.The distal lumen was found to be occluded with what appeared to be dry clotted blood.After removal of the occluded material all through lumens were patent without any leakage or occlusion.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.

• 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: 9602568
• MDR Text Key: 188655563
• Report Number: 2015691-2020-10230
• 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
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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: 02/27/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1