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

Model Number 774F75

Device Problems Pacing Problem (1439); Unstable (1667)

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

Event Date 12/10/2019

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 device met all specifications upon distribution.

Event Description

It was reported that blood temperature value was unstable during use.The indicated blood temperature value was widely fluctuated between 5 degrees c to 40 degrees c.The cable and the monitor were replaced but the problem was not solved.The patient was not treated based on the incorrect value.It is unknown if an error message was observed.It is unknown if there was an occlusion, leakage or kink noted in the catheter.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks with one pressure tube was returned for evaluation.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.However, the catheter was connected to vigilance ii monitor and "check thermal filament connection" error message was shown.No visible inconsistency was observed on eeprom data.Continuity testing confirmed a full open condition in the thermal filament circuit.The thermal filament connector was opened.Continuity test confirmed an open condition at the solder joint between one leadwire and circuit board inside the thermal filament connector.No visible damage or abnormalities to the catheter body, balloon or returned syringe was observed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examinations were performed under microscope at 10x magnification and with the unaided eyes.Customer report of blood temperature measurement issue could not be confirmed during the analysis, however, a full open condition in the thermal filament circuit 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.The patient¿s body temperature by can be obtained by different means and compared to the temperature obtained from the catheter.If they do not correlate to the clinician¿s satisfaction, the clinician an start the troubleshooting process or abort the attempt to obtain cardiac output.The catheter can be exchanged if desired.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

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: 9508625
• MDR Text Key: 188679557
• Report Number: 2015691-2019-04849
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 62218824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1