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

Model Number 777F8

Device Problem Incorrect Measurement (1383)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

It was reported that during three days of monitoring hemodynamic data via a model 777f8 swan ganz catheter, different values for cardiac index were displayed.The ci values ranged from 1.7 to 1.8, however, when the fick method was calculated, the result was over 3.It was noted that on day 1 of monitoring, flotrac was started with a ci value of 2.8 while the swan ganz was reading a ci of 1.8.Troubleshooting included changing out the 70cc2 cable on the hemosphere.There was no report of patient injury.The lot number of the suspect device was unknown.

Manufacturer Narrative

One 777f8 catheter was returned for evaluation.The customer report of the cardiac index issue was unable to be confirmed.There were no fault messages that showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 37.0 degrees c when submerged into a 37.0 degrees c water bath.The catheter ran cco in 37.0 degree c water bath on hemosphere monitor for 5 minutes with no errors.The thermistor and thermal filament circuits were continuous.There were no open or intermittent conditions.There were no visible inconsistencies observed on the eeprom data.The resistance value of thermal filament circuit was measured 36.88 ohms.Both the thermistor and thermal filament connectors were opened and found no visible inconsistencies.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.There was no visible damage or inconsistencies observed from the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was completed 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 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/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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15200171
• MDR Text Key: 305044832
• Report Number: 2015691-2022-07248
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)231222(11)211222(10)64128949
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64128949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1