MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

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 be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.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.

Event Description

It was reported that resistance was felt when inserting a guidewire into the catheter during use.It was also reported that inaccurate pressure value was observed and the indicated value was higher than the customer expected.The issue was resolved by replacing the catheter.It is unknown which pressure value was inaccurate.There were no patient complications reported.Date of event is unknown.

Manufacturer Narrative

Additional information was reported from the sales rep.It was unable to confirm which pressure value was inaccurate.The indicated pressure value was from 20 to 30 mmhg on a monitor.The expected value was around 0 mmhg since it was after zeroing.The issue was resolved by replacing the catheter, therefore the malfunction of pressure transducer was not suspected.The patient was not treated based on the incorrect value.Certain amount of pressure was observed continuously on the pressure waveform.The pressure value and the waveform did not match.The sample of tracing was unavailable.No error message was observed.The value was not affected by the patient condition.The patient was male, and other information was unavailable.Although resistance was felt when inserting the guidewire, it was able to pass through the catheter.The customer suspected that inaccurate value was observed due to an occlusion inside one of the lumens.Further information could not be obtained.The reported event of pressure measurement issue and guidewire insertion issue were unable to be confirmed during product evaluation.Edwards pressure monitoring ifu rev.A state, poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.As received, liquid was observed inside of the balloon.An interlumen leak was observed between balloon inflation lumen and pa distal lumen at the backform.Balloon did not maintain its inflation due to leakage from pa distal hub.Other through lumens were patent without any leakage or occlusion.Recommended guidewire size for this model is 0.021 inches per japan ifu.Lab sample 0.021 inch guidewires passed through pa distal lumen from tip to hub and from hub to tip without any restrictions.No visible damage was observed from catheter body, balloon, and returned syringe.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 CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16042845
• MDR Text Key: 306450452
• Report Number: 2015691-2022-10319
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• 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: 01/05/2023

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 Expiration Date: 01/20/2024
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64200102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2022
• 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