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

Model Number 774F75

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The swan ganz catheter evaluation is in progress.A supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.

Event Description

It was reported that cardiac index (ci) and cardiac output (co) values were higher than expected on the first day of use.It is unknown if an error message was displayed.The catheter was not exchanged.There was no occlusion, leakage or kink noted in the catheter.Information such as indicated value, expected value or if other trouble shooting was performed was not available.It is unknown if the patient was treated based on the incorrect value or if the value was affected by the patient condition patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One swan ganz catheter with attached monoject 1.5 cc limited volume syringe, 2 three-way stopcocks, and one pressure tube was returned for evaluation.A non-edwards introducer with contamination shield was located on the catheter body between 73.5 cm and 109 cm proximal from catheter tip.Blood was visible on catheter body.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 40.88 ohms.Both thermistor and thermal filament connectors were opened and no visible inconsistencies were found.When the non-edwards contamination shield was removed from the catheter body, an indentation was found under the contamination shield proximal connector, located at 109 cm from the catheter tip.In addition, the distal heater bonding was torn and blood was observed inside the heater shrink wrapping.No other visible damage or inconsistency was observed from the catheter body, balloon or returned syringe.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.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eye.The lot number was obtained from the eeprom data during evaluation and a device history record review was completed and documented that the device met all specifications upon distribution.Customer report of cco measurement issue could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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.

• 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: 11118334
• MDR Text Key: 227072843
• Report Number: 2015691-2021-00019
• Device Sequence Number: 1
• Product Code: DYG
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63144364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1