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

Model Number SWAN-GANZ UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 11/01/2013

Event Type  Injury  

Manufacturer Narrative

As reported, while using this swan ganz catheter catheter postoperatively after a surgical repair to resolve severe mitral insufficiency from large perivalvular leak (complaint registered as (b)(4), patient suffered superior cava syndrome (swelling of the face, neck, upper extremities and trunk).Svc syndrome is a consequence from either partial or complete obstruction of blood flow through the svc, and in this case the patient had a thrombus obstructing the left jugular.The swan-ganz was presumably placed in the right jugular, and the combination of both events contributed to the development of svc syndrome.It was resolved after removal of central venous catheter and the swan ganz catheter.There is no statement in the instructions for use regarding this syndrome and it usually develop slowly; however, it can worsen quickly causing life-threatening problems with breathing and turning into a medical emergency.The event was found through the medical records of a surgical repair to resolve severe mitral insufficiency from large perivalvular leak.There was no allegation or indication of device malfunction.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.

Event Description

As reported, during use of this swan ganz catheter, postoperatively after a surgical repair to resolve severe mitral insufficiency from large perivalvular leak, patient suffered superior cava syndrome (swelling of the face, neck, upper extremities and trunk).It was resolved after removal of central venous catheter and the swan ganz catheter.The device was not available for evaluation.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16093379
• MDR Text Key: 306592818
• Report Number: 2015691-2023-09945
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• 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: 12/12/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 52 KG