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

Model Number 131F7J

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

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

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 the indicated pulmonary artery wedge pressure value was low since the pawp did not rise properly during use.The catheter, disposable pressure transducer, cable and monitor were not replaced.The customer was uncertain whether the issue was due to the catheter malfunction.Indicated value, expected value, if an abnormal waveform was observed, if the value and the waveform matched, if the patient was treated based on the incorrect value, if the data log is available, if other trouble shooting were performed, if an error message was observed, if occlusion, leakage or kink was noted in the catheter, and if the value was affected by the patient condition is unknown.Patient demographic information was requested but unavailable.The details will be followed up by the sales rep.There were no patient complications reported.Date of event is unknown.

Manufacturer Narrative

The reported event of pressure issue was not able to be confirmed during evaluation.Per edwards pressure monitoring ifu rev.A, poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively complaint pressure tubing, small bore tubing, loose connections, or leaks.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from catheter body, balloon and returned syringe.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.Catheter passed the pressure test with lab dpt.Further evaluation regarding supplier related quality issues is under investigation.New information during event was obtained from sales representative.Refer to b5 for details.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

Additional information was reported from the sales rep.Per follow up, non edwards dpt from merit medical and non edwards monitor, nihon kohden polygraph, was used.The indicated pawp value on the monitor was 2 mmhg, whereas expected value was between 6 and 12 mmhg.The cable was replaced but the problem was not solved.The patient was not treated based on the incorrect value.No abnormal waveform or error message was observed.There was no occlusion, leakage or kink noted in the catheter.The sample of tracing was unavailable.Information such as if the value and the waveform matched or if the value was affected by the patient condition was unavailable.The patient gender is female, and other information was unavailable.

Manufacturer Narrative

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
• 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: 14350302
• MDR Text Key: 291391829
• Report Number: 2015691-2022-05657
• 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,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/20/2023
• Device Model Number: 131F7J
• 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: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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
• Patient Sex: Female