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

Model Number 774F75

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/17/2018

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that an inaccurate svo2 value was observed during use.Indicated svo2 value was 30% to 40%.The catheter was not exchanged.To troubleshoot the issue, blood samples were collected from each lumen and blood gas was analyzed.The resulting svo2 values of all blood samples were similar to the value indicated with the swan ganz catheter.It is unknown if an error message was observed or if there was an occlusion, leakage or kink noted in the catheter.It is unknown if an abnormal waveform was observed or if the pressure value and waveform matched.It is unknown if the patient was treated based on the incorrect value or if the value was affected by the patient condition.No further information could be obtained.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 was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 34 cm and 77 cm proximal from the catheter tip.No packaging or cal-cup was returned with the unit.No visible damage or inconsistency to the catheter body, balloon or returned syringe was observed.No fault messages appeared on the lab vigilance ii monitor when the catheter was connected.Catheter passed in-vitro calibration on vigilance ii monitor.The thermistor was found to read 36.9 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 thermal filament circuit was within specification, measuring 38.90 ohms.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.Further evaluation confirmed that the catheter passed attenuation test.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 eyes.Customer report of svo2 measurement issue could not be confirmed during the analysis.The catheter responded appropriately during functional testing.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, blood gas samples were taken and matched the svo2 readings from the catheter.It is unknown whether any user or procedural factors may have contributed to the stated event.There were no patient complications noted.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

The lot number was obtained and a device history record review was completed and documented that the device met all specifications upon distribution.

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; anaso PR 00610
• MDR Report Key: 8224728
• MDR Text Key: 133086030
• Report Number: 2015691-2019-00097
• 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,Followup
• Report Date: 12/17/2018

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: 05/10/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61389784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/15/2019; 03/11/2019; 07/23/2020
• Supplement Dates FDA Received: 01/31/2019; 03/15/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1