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

Model Number 774F75

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

One 774f75 catheter with attached monoject 1.5 cc limited volume syringe, 2 three way stopcocks, and non ew introducer with contamination shield which is located on the catheter body between 3.5 cm and 98.8 cm proximal from tip was received for evaluation.There was blood visible on catheter body.The customers report of the cco measurement issue was confirmed.As received, the thermal filament cover was torn, and thermal filament was damaged at approximately 21 cm from catheter tip.The edges of the thermal filament cover were not able to match up.After removing the thermal filament, surface damage was observed on catheter tube under the damaged area of the thermal filament.The catheter was connected to a hemosphere monitor and the error message connect thermal filament for co monitoring was shown.An open condition was confirmed on the thermal filament.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.Thermal filament connector was opened with no visible abnormalities.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric, and remained inflated for more than five minutes without leakage.The distal heater bonding was torn, and blood was observed inside the heater shrink wrapping.The torn edges appeared to match up.An indentation was observed on catheter body at 98.8 cm proximal from catheter tip.The location of the indentation aligned to the location of non edwards contamination shield adapter.There was no visible damage found from the balloon and returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that an error message asking to check the thermal filament appeared, and measurement of continuous cardiac output (cco) stopped on the first day of use.The issue was not resolved by replacing the hemosphere monitor.There was no injury or complication occurred.During the product evaluation, the thermal filament cover was torn and thermal filament was damaged at approximately 21 cm from catheter tip.The edges of the thermal filament cover were not able to match up.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13423991
• MDR Text Key: 284999999
• Report Number: 2015691-2022-03748
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2022

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: 12/04/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63511635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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