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

Model Number 777F8

Device Problems No Device Output (1435); Material Rupture (1546)

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

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe, one three-way stopcock, and two injection ports was returned for evaluation.A non-edwards introducer with non-edwards contamination shield was located on the catheter body between 53.8 cm and 108 cm proximal from the catheter tip.Clotted blood was observed from the catheter.As received, a tear on the thermal filament and cover, 1.5 mm x 1.5 mm, was found at approximately 21 cm from the catheter tip.The edges of thermal filament and the cover did not match up.The catheter was connected to vigilance ii monitor and "check thermal filament connection" error message was shown.An open condition was confirmed on the thermal filament.The thermal filament trace was damaged at the tear.After removing the thermal filament and cover, no visible damage was found on the catheter tube.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.The thermistor circuit was continuous and there were no open or intermittent conditions observed.No visible inconsistency was observed on eeprom data.The thermal filament connector was opened and no visible abnormalities were 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.No visible damage to the balloon, connectors or returned syringe was found.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of cco measurement issue was confirmed.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.

Event Description

It was reported that the cco value was not shown on the monitor after pump-off although cco measurement was available in the beginning of the cardiac surgery.The cable was replaced but the problem was not solved.The customer attempted to restart the measurement after the patient was moved to the icu, but it could not be measured.The catheter was not replaced.It is unknown if an error message was displayed.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV 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
• MDR Report Key: 10290286
• MDR Text Key: 199991550
• Report Number: 2015691-2020-12558
• 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
• Report Date: 06/12/2020

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: 11/11/2021
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 62729071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1