MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWANG-GANZ IQ PULMONARY ARTERY CATHETER; CATHETER, FLOW DIRECTED

Model Number 141F7

Device Problems Unable to Obtain Readings (1516); No Pacing (3268)

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

Event Date 02/11/2023

Event Type  malfunction  

Manufacturer Narrative

One catheter was received by our product evaluation laboratory for a full examination.The customer report of "it could not measure the temperature" was confirmed.As received, the catheter was connected to vigilance ii monitor and it was noted that temperature value was intermittently shown.The thermistor circuit was found to be intermittent when flexing next to the proximal end of the thermistor bead.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from catheter body or returned syringe.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.

Event Description

As reported, during use in patient and when using this swan-ganz catheter for right heart monitoring, it could not measure the temperature when measuring cardiac output.Nevertheless, it measured the patient's right heart pressure, right atrial pressure, right ventricular pressure and pulmonary artery pressure, as well as pulmonary artery wedge pressure.As troubleshooting, the monitor module was replaced, but the issue remained.The issue was solved by replacing the catheter with a new one by removing the non-ew introducer and starting from the beginning using a new introducer in a new insertion site.The catheter was used with philips mx800 monitor.There was no allegation of patient injury.Patient information was unavailable.The device was available for evaluation.

Manufacturer Narrative

H10 manufacturer narrative: further investigation completed by engineers in the manufacturing site.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Additionally, it could be verified that as part of the manufacturing process, the units go through a visual and electrical inspection process in place to prevent this type of malfunction in our manufacturing process.Edwards will continue to review and monitor all events.

• Brand Name: SWANG-GANZ IQ PULMONARY ARTERY CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16804925
• MDR Text Key: 313906686
• Report Number: 2015691-2023-12545
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: 141F7
• Device Catalogue Number: 141F7
• Device Lot Number: 63909298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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