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

Model Number 777F8

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

The catheter involved was not available for evaluation, since it was discarded.Therefore; a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Further investigation was completed by the engineers in the manufacturing site.There are current controls in place to prevent this type of malfunction in our manufacturing process.Additionally, the manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.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, during use in patient with this swan ganz catheter, a cco error message regarding "filament problem" was suddenly displayed.However; there was no problem at the startup of the device.As troubleshooting, a different cco cable was tried, but the issue remained the same.The catheter remained in place to keep measuring svo2.Later on, the patient had a redo surgery, and when they took a look in the vena cava, it was observed that the catheter was sutured in the vena cava.Patient demographics were not available.The catheter was not available for evaluation since it was discarded.

Manufacturer Narrative

Upon further review, health effect - impact code and device codes were corrected in order to better reflect the nature of the finding.

Manufacturer Narrative

Additional information was received that "when trying to remove the catheter, it was found stuck.Therefore, a redo surgery to remove the catheter was performed, since it was observed that the catheter was sutured in the vena cava.There was no catheter replacement after the removal.Customer alleged that the suture was the potential cause of the thermodilution error that occurred." therefore the event description has been updated.In addition, b1 has been corrected to adverse event.As reported, during use a swan ganz cco catheter was accidentally sewn into the vena cava.In this reported event, there was a product malfunction that was caused by the user sewing the catheter into the vena cava.There was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest the root cause is related to use error.There is no statement in the instructions for use regarding suturing of the swan ganz catheter into the vena cava, however, it is considered standard of practice to ensure that the catheter is clear of any sutures connecting the device to an internal anatomical structure, such as the vena cava before closing the chest upon the conclusion of open-heart procedure.This safety check was not performed as the catheter gave resistance upon removal attempt.Due to the removal difficulty, the patient had an additional open procedure to remove the catheter from the vena cava.Additionally, the patient is at risk for potential tissue damage and/or bleeding.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.The corrected information is being submitted to address the risk to the patient of this use error.

Manufacturer Narrative

Upon further review by edwards product safety, the term "use error" was used erroneously in this reported mdr and what actually occurred is termed "procedural error." there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest the root cause is related to a procedural error.The procedural error is one of standard surgical techniques not specific to the use of edwards product.The swan ganz catheter is not meant to be sutured in place during open heart procedures.

• Brand Name: SWAN-GANZ CATHETERS
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14208134
• MDR Text Key: 299176698
• Report Number: 2015691-2022-05415
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64014047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2021
• 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