MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN GANZ TRUE SIZE CATHETER; CATHETER, FLOW DIRECTED

Model Number 131F7

Device Problem Incorrect Measurement (1383)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

One swan-ganz catheter was received by our product evaluation laboratory for a full examination.The report of inaccurate co values could not be confirmed.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read accurately when submerged into a water bath.Thermistor circuit was continuous, there were no open or intermittent conditions.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.No visible damage was observed from catheter body.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, when different users injected saline bolus using the same technique, in some occasions this swan-ganz catheter displayed inaccurate co values.Sometimes, waveform was abnormal and an error message was displayed; however, it was not possible to confirm if they were always shown during the issue.It was the first time the clinicians used a swan ganz catheter.There was no allegation of patient injury.

• Brand Name: SWAN GANZ TRUE SIZE CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17816319
• MDR Text Key: 324224463
• Report Number: 2015691-2023-16167
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2023

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 Model Number: 131F7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male