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

Model Number 774F75

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

Patient Problem Great Vessel Perforation (2152)

Event Date 02/15/2024

Event Type  Death  

Event Description

As reported, while placing this swan-ganz catheter for long-term assistance in a patient with a cardiogenic shock hospitalized for one month, a massive hemoptysis occurred within 5-10 minutes of stopping attempts to measure pulmonary artery occlusion pressure (paop), leading to patient death.The customer suspected a pulmonary artery rupture.The preparation and insertion was performed by 4 hands, checking each step carefully.In particular, it was unable to obtain paop, even after checking the correct positioning on x-ray.By the time the catheter was pulled back slightly, the balloon was properly deflated.There was no allegation of product malfunction.

Manufacturer Narrative

As reported, while placing this swan-ganz catheter, a massive hemoptysis occurred within 5-10 minutes of stopping attempts to measure pulmonary artery occlusion pressure (paop), leading to patient death.The customer suspected a pulmonary artery rupture.In this event, the patient was hospitalized for cardiogenic shock due to three-vessels-coronary artery disease and as stated by the facility, the patient was on anticoagulation and bled easily with each puncture.The preparation and insertion was performed by 4 hands, checking each step carefully.In particular, it was unable to obtain paop, even after checking the correct positioning on x-ray.By the time the catheter was pulled back slightly, the balloon was properly deflated.There was no allegation of product malfunction.The device was not available for evaluation.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.Investigation results indicate 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.The lot number for this device was not supplied, therefore, further review of the related manufacturing records could not be performed.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.No corrective or preventative actions are required at this time.

• Brand Name: SWAN-GANZ CATHETER
• 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: samanth eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18978784
• MDR Text Key: 338600702
• Report Number: 2015691-2024-02307
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 774F75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• 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): Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG