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

Model Number TS105F5

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

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.

Event Description

It was reported that inaccurate co value on a swan ganz catheter was observed on the first day of use.The indicated value on the monitor was higher than 8l per min, whereas normal range of value was expected.The patient was not treated based on the incorrect value.The cable was replaced but the problem was not solved.Then, the issue was resolved by replacing the catheter.No abnormal waveform was observed.The value and the waveform matched.No error message on the monitor was observed.The sample of tracing was unavailable.There was no occlusion, leakage or kink noted in the catheter.The value was not affected by the patient condition.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported event of co measurement issue was not able to be confirmed.No visible damage or abnormality was observed from catheter body, balloon, and syringe.No error message was observed on hemosphere monitor.The thermistor was submerged in a 37.0 c water bath and read 37.0 c on hemosphere monitor.Thermistor temperature reading accuracy is plus minus.3c per hemosphere manual.Thermistor circuit was continuous and there were no open or intermittent conditions.Thermistor connector was opened and found to be no visible abnormalities.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 min.Without leakage.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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 CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13951928
• MDR Text Key: 294516408
• Report Number: 2015691-2022-04715
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/12/2023
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 64072117
• 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: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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