Summary of MedSun Reports Describing Problem With the Continuous Cardiac Output Pulmonary Artery Catheter
MedSun: Newsletter #69, February 2012

The intended use of continuous cardiac output pulmonary artery catheter and continuous cardiac output monitor systems is for the assessment of the patient's hemodynamic condition though direct intra-cardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for the sampling of venous blood (1).

Over the past year, MedSun has received 28 adverse event reports associated with pulmonary artery catheter devices manufactured by Arrow International, Edwards LifeSciences, and ICU Medical. The reports were submitted by 17 hospitals between January 2011 and December 2011. Please note that several reports contain multiple catheters as well as multiple device problems.

The reported device problems were:
• Inaccurate temperature readings - 9
• Balloon rupture/dislodgement – 5
• No wave form – 5
• Error or fault message - 3
• Cardiac output would not register – 2
• Exposed wires on the catheter - 1
• Balloon would not stay inflated - 1
• Difficulty retracting air – 1
• Air leak – 1
• Inability to read pressures properly – 1
• Catheter would not calibrate – 1
• Fluid leaking from port – 1
• Catheter would not wedge – 1
• Monitor did not recognize the catheter – 1
• Physician did not deflate the balloon before removal -1
• Unknown device issues - 2

One report involved a patient death. In addition, the other reported patient problems are also listed, below. Please note some reports identified multiple patient problems.
• Repeat procedure to insert another Swan-Ganz catheter – 11
• Supraventricular tachycardia (SVT) – 1
• Retained balloon fragment – 2
• Death – 1
• Surgical intervention – 1
• Return for repeat procedure - 1
• Potential for harm – 11
• Unknown – 9

Of the reports that listed patient age, there were no reports with a patient age listed as less than 21 years and 24 reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 6 reports involved female patients and a total of 19 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

There are no recalls related to these devices in the past year.

The following table lists the MedSun reports that are described in the device problem summary above.



MedSun Reports Describing Problems with Continuous Cardiac Output Pulmonary Artery Catheter
Device Manufacturer and BrandDevice Identifiers (Model/Catalog/Lot numbers) Event Description
Edwards LifeSciences/CCOmbo V Device # 1: Lot # 59072561; Device #2: Lot # 59041689

The Swan-Ganz was being inserted via Cordis right (RT) internal jugular (IJ) and twice the balloon broke. The depth of first one was about 60 cm but never got a right ventricular (RV) wave. The second one had the same difficulty. The patient has atrial and mitral prosthetic valves. One Swan-Ganz catheter was tagged and send to central supply for follow up. The patient was maintained with a triple lumen catheter and arterial line. The patient was managed by medical crital care (MCC) and discharged 4 days later.
Edwards LifeSciences/VIP+ Six Lumen Catheter
Model # 834HF75 Cardiac output port came apart between the white connection and the yellow catheter portion leaving exposed wire. When discovered, the catheter was discontinued. The device was not replaced and there was no patient injury.
Edwards LifeSciences/Swan Ganz CCO VIP
Device 1: Model # 139HF75P, Lot # 59003326; Device 2: Model # 139HF75P Lot # 59026127; Device 3: Model # 139HF75P, Lot # 59026127



1st case: open heart case: The surgeon thought the wave forms looked funny and the cardiac index read 10 and there was a fault message about the filaments, Swan changed out during case then worked fine. 2nd case: Patient in OR for open heart surgery, after patient was intubated, the anesthesiologist passed the Swan Ganz which gave pressures on the monitor but was not reading any wave forms. A new Swan Ganz was opened and it worked successfully with all readings coming across the monitor. 3rd case: No patient information, only the swan w/note that state "bad" on sticker.
Edwards LifeSciences/Thermodilution catheter Catalog # 1317P,
Lot # 59053852
Swan Ganz catheter did not sense blood temperature. Unable to use and had to replace it. There were no problems noted in placing the catheter. The patient was discharged in stable condition but is going to have to repeat the procedure to get a definitive diagnosis.
Edwards LifeSciences/ControlCath Model # C146F7
Lot # 58888828
The patient who is status post coronary artery bypass graft (CABG) went to the cath lab for diagnostics due to increasing congestive heart failure and respiratory failure. After the Swan-Ganz Thermodilution Catheter, pulmonary artery catheter, was placed, the doctor attempted to inflate the balloon and the balloon would not stay inflated. The doctor had to place a different catheter. He opened another Swan and had no difficulty with the balloon. The patient did fine; there was no ill-sequelae due to the inability of the balloon to stay inflated.
Edwards LifeSciences/Swan-Ganz PAC VIP Five Lumen
Model # 831F75
The RN was informed of difficulty retracting air. An additional attempt made by the RN. The physicians were informed at this time. An order for critical chest x-ray received at approximately 1 pm. At that time, the monitor shows supraventricular tachycardia (SVT) at 170-210. The house staff were at the bedside. The dobutamine was turned off at this time. Adenosine 6 mg given IV push per physician's order. The patient's heart rate slowed momentarily, then resumed a rate of 140's in atrial flutter. Amiodarone 150mg bolus given at this time per physician's order. The rate slowed to a baseline of sinus tachycardia in 120's. All other vital signs were stable as seen on the flowsheet. The order was received to remove the swan. At approximately 2 pm, the Swan-Ganz catheter was removed, with the balloon fully intact, however, an air leak was noted. The house staff was informed at this time. Cordis left in place and obturator applied. Chest x-ray obtained. It is unknown if episode of SVT was due to the suspected air leak in balloon or from the dobutamine.
Edwards LifeSciences/Swan-Ganz CCO/VIP
Model# 139HF75P
Lot # 58930373
The equipment malfunctioned. Submitting report to clear queue. No further information is available and no action is expected.
Edwards LifeSciences/Swan-Ganz CCO/VIP Catalog # 139HG75P
Lot # 58987967
The Swan Ganz catheter was inserted by the anesthesiologist and was not reading the pressure properly. Device was removed and a second was inserted and was working properly. No other specifics or further information regarding the device malfunction was reported.
Edwards LifeSciences/Swan Ganz CCOmbo Catalog # 746HF8
Lot # 58984700
The catheter would not calibrate. Multiple attempts were made.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen
UNK Checked the pulmonary artery (PA) catheter temperature and it read 104.5. Took the temperature axillary, tempanic, temporal and the readings were 102.4. Called Biomed to check out the monitor and the cables. They found nothing wrong with the cables. The cables and modules were replaced with no change noted. ====================== Manufacturer response for Thermodilution Venous Infusion Port (VIP), Swan Ganz (per site reporter) ====================== They are sending return packaging so the device can be returned to them.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen Model # 831HF75
The ICU nurse was checking the patient's temperature. The readings were off. No exact information available except the PA reading was higher than the tempanic, temporal, and oral reading by a few degrees (2 or 3). The ICU nurse changed out all modules and cables with no apparent changes. Biomed was then called in to examine the monitor and all cables. They found no apparent problems.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen Model # 831HF75
The ICU nurse was checking the patient's temperature. The reading from the Swan Ganz PA Catheter was reading 101 degrees. When the temperature was taken by tympanic, temporal, and orally they registered 97.6 degrees. The nurse changed the cables and modules. Called Biomed and they checked all cables and modules used on the patient. They were all found to be working correctly.
Edwards LifeSciences/Thermodilution Venous Infusion Port (VIP) Five Lumen Model # 831HF75
Lot # 58971113
The patient's Swan Ganz was attached to the GE Marquette monitor. The temperature reading was 104.0 degrees. When the temperature was taken temporally it registered at 98.2 degrees. All cables were changed and the module. This did not change the results. The patient was afebrile. Biomed was called in and the monitor was checked as well as modules and all cables involved. Equipment and cables were found to be in working order.
Arrow International/Arrow Wedge Pressure Cathete Catalog # AI-07127, Lot # MF0095014

Used product, it appeared to perform successful measurements. When removed from patient, it was noticed that the rubber balloon on the end of the catheter was not there.
Edwards LifeSciences/Swan-Ganz CCO
Model # 139HF75P
Swan Ganz CCO/VIP was placed through the Cordis Introducer. When the pulmonary artery line was flushed, fluid came out of the central venous pressure port on the catheter. When the central venous pressure line was flushed, fluid came out of the pulmonary artery port on the catheter. The anesthesiologist removed the line and placed a new one that functioned properly.
Edwards LifeSciences/HiShore TD Model # 141HF7
Patient with congestive heart failure and cardiomyopathy had Swan-Ganz catheter. The catheter was not wedging. The catheter advanced by MD, and an x-ray was obtained to confirm placement. A hemodynamic profile was ordered and the catheter wedged without resistance. Following the wedge, the patient began coughing, initially stable, but rapidly progressed to arrest and patient expired. Patient was being worked up as a VAD and transplant candidate.
Edwards LifeSciences/Swan-Ganz Lot # 58943639, 58943617, 58901477
The doctor attempted to place the Swan Ganz catheter twice. He was not able to obtain the correct wave form on the patient monitor while inserting. Upon discontinuing the catheter, it was noted that the tip of the balloon was ruptured or missing.
Edwards LifeSciences/Swan-Ganz CCO/VIP
Model # 139HF75P, Lot # 58983645
During an open heart case, physician inserting right subclavian sheath with a CCO Swan. When Swan was hooked up the Vigilance II monitor, indicator showed there was something wrong with the connection. Team switched out Vigilance II Monitors and cables and got same message. Clinical Engineering tested cable, all was fine. Swan removed and new one placed and all worked fine.
ICU Medical/UNK Lot # 92-024-2A
A thermodilution catheter (or Pulmonary Artery catheter) allows us to calculate a cardiac output and continuously monitors the temperature of the blood (a patient's core temp). The monitoring difficulties we were having were originally that the monitor was not continuously recognizing the catheter and the cardiac output option would turn on and off by itself. After troubleshooting, we also realized that the temperature reading was fluctuating very quickly from one extreme to the other. After an hour with Medical Engineering, we felt all the monitoring equipment was working correctly and that the problems may be stemming from a damaged thermistor on the catheter itself.
Edwards LifeSciences/Swan Ganz CCO/VIP
Model # 139HF75P, Lot # 58930373

The Swan Ganz catheter was inserted and the anesthesiologist noted that the cardiac output was not registering. A new Swan Ganz catheter was inserted and hooked up to the same equipment and worked properly registering the cardiac output.
Edwards LifeSciences/Swan Ganz CCO/VIP
Model # 139HF75P, Lot # 58878963

Patient had left heart catheterization, coronary angiogram, insertion of swan-ganz and balloon pump. Difficulty advancing the swan and when removal was attempted, the balloon was dislodged. The problem did not occur with initial insertion. It was felt that it happened because there was difficulty and too much pressure was used. Further, the physician did not deflate the balloon before pulling it back. Tried to snare balloon, but unsuccessful. IVC filter placed instead. It is planned that the balloon will be removed once the patient improves and becomes stronger.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75

I spoke with the nurse in the ICU who had the Swan-Ganz catheter. She stated, when the patient first arrived and was hooked up to the physiological monitors, the temperature would register normal thermal 98 degrees. After awhile it would slowly creep up until it registered 104 degrees. She said that they took the tympanic temperature, temple, and orally and they were normal thermal. She even checked the patient to make sure they did not feel warm. She said they changed the cables, module and used a different monitor. None of these changes made a difference. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Sending box in to return and sending a replacement. Will also send report after examination of product.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75
The pulmonary artery catheter (PAC) temperature was 103.8 and did not correlate with the patient's temperature when using other methods. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Called and left detailed message. Waiting for response.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75
The pulmonary artery catheter (PAC) temperature was 103 degrees. The tympanic temperature was 100.7 degrees. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Waiting for them to call back.
Edwards LifeSciences/Swan-Ganz, VIP
Model # 831HF75, Lot # 58933168

The pulmonary artery catheter supplied the patient's temperature as being 104 degrees, but the temperature of the patient was between 98-99 degrees. The patient's temperature was checked several different ways. The cables were changed several times which made no difference. Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP: Will notify the company today.
Edwards LifeSciences/Synthetic ControlCath TD Model # C146F7
(listed as other device # in report) Lot # 588875019
Balloon on catheter ruptured in patient's heart during procedure. Latex free Swan-Ganz. Patient had highly calcified vessels. Swan difficult to advance. On fluoroscopy exam, the balloon was found to be ruptured. The balloon appeared intact upon inspection.
Edwards LifeSciences/Swan Ganz CCO/VIP
Model # 139HF75P, Lot # 58915467
Swan Ganz catheter placed in the OR by anesthesiologist prior to emergency coronary bypass surgery. The cardiac output monitor was not functioning. Swan Ganz cable changed but still not monitoring. Swan Ganz catheter replaced after surgery. No patient harm.
Edwards LifeSciences/Swan Ganz CCO SVo2 VIP
Model # 777HF8
Lot # 58943356
Swan catheter was giving a "fault" reading after insertion. The catheter was removed and a new swan was inserted. Other reports of similar 'fault readings".


Additional Information:

1. 510(k) Summary. July 22, 2008. Retrieved from:
http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081776.pdf


MedSun Newsletters are available at www.fda.gov/cdrh/medsun