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

Model Number 777F8

Device Problem Material Fragmentation (1261)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

It was reported that during a cardiac procedure, a model 777f8 swan ganz catheter was unable to measure continuous cardiac output, aka cco, and cardiac index, aka ci, on the hemosphere monitor.Post-operatively in the icu, cco was still not able to be measured.A cable test was performed by both the day shift and the night shift and the 70cc2 cable passed both times.It is unknown if an error message was observed on the monitor.There were no patient complications reported.The lot number was unknown.

Manufacturer Narrative

Our product evaluation lab received one model 777f8 catheter with an attached monoject 1.5cc limited volume syringe, x1 three-way stopcock, x1 pressure monitoring set, and a non-ew introducer with contamination shield located from the tip to 47.3cm proximal from the tip.As received, the thermal filament cover was torn approximately 0.5mm at 17.3cm and around the circumference at 17.5cm.The edges of the thermal filament cover around 17.5cm were not able to match up.Two punctures, opposite of each other, were observed at 17.5cm.Puncture a, measuring approximately 0.5mm, was on the catheter body.Puncture b, measuring approximately 1.0mm, was on the thermal filament trace.Puncture a entered the pa distal lumen with air leakage observed from the puncture site when a leak test was performed.Other through lumens were patent without any leakage or occlusion.The catheter was connected to a hemosphere monitor and the check thermal filament connection error message was shown.The thermistor read 37.0 degrees celsius when submerged into a 37.1 degree celsius water bath, which was within accuracy per the hemosphere manual.The thermistor circuit was continuous and there were no open or intermittent conditions observed.No visible inconsistency was observed on eeprom data.Both the thermistor and thermal filament connector were opened with no visible abnormalities.The balloon inflated clear and concentric, and remained inflated for more than 5 timed minutes without leakage.The distal thermal filament bonding site was torn, and the edges appeared to match up.No visible damage was found from the balloon and returned syringe.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The customer report of a cco measurement issue was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Per engineering, eeprom data provided the lot number as 64540148.A device history record review was completed and documented that the device met all specifications upon distribution.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16726215
• MDR Text Key: 313152969
• Report Number: 2015691-2023-12265
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240802(11)220803(10)64540148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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 Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64540148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2022
• 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