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

Model Number SWAN GANZ UNKNOWN

Device Problem Difficult to Remove (1528)

Patient Problems Physical Entrapment (2327); Swelling/ Edema (4577)

Event Date 09/18/2023

Event Type  Injury  

Event Description

It was reported that during use, this swan-ganz catheter was unable to be removed from the patient.Post-op day 1, the swan-ganz catheter was unable to be removed at the bedside.The patient was required to return to the operating room for a redo sternotomy and removal of the swan-ganz catheter as it was caught in the superior vena cava stitch.The patient made excellent recovery progress and was discharged to home on post-op day 6.

Manufacturer Narrative

The device has not been returned for evaluation and it is not known if it is available for return.A supplemental report will be forthcoming with the evaluation results if it is received.A device history record review was unable to be completed as the lot number is unknown.There is no statement in the instructions for use (ifu) regarding suturing of the swan into the cardiac structure, however, it is considered standard of practice to ensure that the catheter is clear of any sutures connecting the device to any cardiac structures before closing the chest upon the conclusion of open-heart procedure.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results indicate the root cause is related to a procedural error.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.H3 other text : device not returned.

Manufacturer Narrative

The device will not be returned for evaluation.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.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.Corrected data: health effect - clinical code updated to physical entrapment.

• Brand Name: SWAN-GANZ CATHETER UNKNOWN
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): +1(949)201-7706; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18111463
• MDR Text Key: 327880019
• Report Number: 2015691-2023-17400
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Hospitalization
• Patient Sex: Male