MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ THERMODILUTION PACEPORT CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 931F75

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

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that serosanguineous fluid leaked multiple times from the thermistor part of a swan ganz pulmonary artery.First leakage occurred once the red cap was removed and before the nurse connected the temperature cables to the thermistor part.Port was cleaned and dried, and was able to connect.The initial temperature of the patient was appropriate.However, the reading began to fluctuate.Nurse rechecked the thermistor port and noticed there was more serosanguineous fluid.With the pa and intensivist at bedside, thermistor port was cleaned again, but the port began to fill again with fluid when the port was held upright.Per the nurse, the fluid caused unreliable patient temperature which resulted with unreliable cardiac indexes.The team replaced the catheter to resolve the issue.Issue occurred in the cticu.Per follow up with customer, the catheter was placed in the or.No error messages were displayed on the monitor during event.The only indication of the issue was the fluctuating temperature readings and inaccurate numbers.No new introducer was needed.The exchange of catheter caused delay in extubation and ectopy was noticed with the new catheter, which was an expected variance.There were no overall patient harm and patient is well.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

Manufacturer Narrative

The reported leaked event was confirmed.As received, blood was observed in thermistor connector.A 0.01 inch puncture hole at the center of a 0.1 inch indentation was found on the catheter body at approximately 13 cm proximal from the tip.The puncture hole entered thermistor lumen.All through lumen were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No other visible damage was observed from the catheter.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.

• Brand Name: SWAN GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17154064
• MDR Text Key: 317638476
• Report Number: 2015691-2023-14007
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 931F75
• 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: 07/27/2023
• 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