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

Model Number	SWAN GANZ UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Respiratory Arrest (4461)
Date of Event	07/16/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported from an anonymous facility that a patient died during a right heart catheterization prior to a cardiomems implant procedure.The physician inserted a medtronic 0.18 nitrex guidewire and advanced the guidewire to the pulmonary artery and used a swan ganz catheter over the guidewire.The patient coughed a few times, and the right heart catheterization was continued.The patient then experienced hemoptysis and resuscitation was attempted as the patient was deteriorating.A thoracotomy was completed in an attempt to stop the bleeding, but the patient died in the cath lab.Cardiomems sensor was not opened or inserted into the body.Cause of death was not specifically identified, but the physician believed that there was a perforation, however one could not be identified.It was noted that the patient also experienced cardiac arrest, bleeding, and respiratory arrest.
Additional Manufacturer Narrative
It is unknown of the model and lot number and if the product will be returned, but follow up is not possible as the medwatch report was anonymous.If the device is returned a supplemental report will be submitted with additional information and evaluation results.Additional product codes are dqe and dqo.Per the instructions for use, pulmonary artery perforation is a known potential adverse event which has been identified as a possible complication of the use of pulmonary artery catheters, such as the swan ganz.There are multiple patient and procedural factors that alone or in combination can cause or contribute to pulmonary artery perforation, including pulmonary hypertension, advanced age, cardiac surgery with hypothermia and anticoagulation, distal catheter tip migration, arteriovenous fistula formation and other vascular traumas.Extreme care should therefore be exercised during the measurement of pulmonary artery wedge pressure in patients with pulmonary hypertension.In all patients, balloon inflation should be limited to two respiratory cycles, or 10 to 15 seconds.A central location of the catheter tip near the hilum of the lung may prevent pulmonary artery perforation.Early clinical symptoms of a pulmonary artery perforation include hemoptysis of bright red blood and or hypotension.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The report stated that the physician advanced the medtronic guidewire to the pulmonary artery and then advanced the swan ganz catheter over the guidewire.The ifu instructs to use the modified seldinger technique to insert the guidewire.The technique requires that the catheter is advanced, and the guidewire is removed before entering the heart, which is standard clinical practice.The report indicates that the root cause is not likely to be related to the swan ganz device.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions or 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.

• Brand Name: SWAN GANZ UNKNOWN
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20075781
• Report Number: 2015691-2024-06469
• Device Sequence Number: 3200225
• Product Code: DYG
• UDI-Device Identifier: 00690103198430
• UDI-Public: 00690103198430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown