Introduction
The heart and the cardiovascular system is the center of our body and the need to correct any irregularities to keep pumping blood is vital to sustaining life. Enter the Pacel Flow Directed Pacing Catheter.
The Pacel Flow Directed Pacing Catheter is used in temporary right ventricular pacing. The catheter is meant to establish temporary right ventricular pacing in patients via electrodes at the catheter tip that allow for bipolar pacing and ECG monitoring. By stimulating the right ventricle, adult patients with congenital heart defects, enlarged or thick muscles and heart failure can have their life saved through this device.
The presentation will go over the regulatory information, foreseeable risks, clinical effectiveness and so much more on the Pacel Flow Directed Pacing Catheter.
Regulatory Description
Device:Electrode, Pacemaker, Temporary
Product Code LDF
Submission Type: 510(k)
Regulation Number: Sec. 870.3680
(b) Classification. Class II (performance standards).
Results
Intended Use:
The Pacel Flow™ Directed Pacing Catheter will temporarily treat patients with cardiovascular issues.
The catheter provides proper pacing of the right ventricle [3]. The target population for this device
are adults who are at high risk for cardiovascular diseases such as arrhythmia and acute myocardial infarction.
Through the stimulation of the right ventricle, these diseases can be properly treated to ensure that the patient is healthy.
Clinical Use:
How it works
The directed pacing catheter works by stimulating the right ventricle through the insertion of an
inflatable balloon transvenously. his balloon is connected to catheter which is connected to a pace generator
that sends electrical impulses to and from the device (figure 2).
Clinical Purpose
The clinical purpose of this device is to treat arrhythmia which is a medical condition that causes the
heart to beat too fast, too slow, or skip beats. This device is created to be installed without fluoroscopy guidance.
Technological Aspect
The catheter is connected to a pacemaker which sends electrical impulses that establish proper heart rhythm.
Electrodes at the catheter tip allow ECG (electrocardiogram) monitoring and bipolar pacing (refer to figure 1).
Additionally, the inflatable balloon (figure 1) which is connected between two platinum electrodes allows for flow directed
positioning without fluoroscopy guidance.
Scientific Principles
Heart arrhythmia causes irregular heartbeat. The pacing catheter is connected to a pacemaker which sends electrical signals
that stimulates the heart, creating a normal rhythm.
Conditions for use
Surgery in a hospital setting is required for this device to be installed. At home the patient must
regularly check the device and the area of surgery for any abnormalities. Additionally the
patient must follow scheduled maintenance of the device.
Clinical Effectiveness:
“Temporary cardiac pacing using a new, steerable, balloon-tipped pacing catheter”[1]
The advantage of a balloon tipped pacing catheter is the ease of achieving a stable contact between the
pacing electrode and endocardium. This study was done on 25 patients with acute myocardial infarction.
“Temporary Transvenous Cardiac Pacing in Patients With Acute Myocardial Infarction Predicts Increased
Mortality”[2]
From a group of patients who suffer from acute myocardial infarction (AMI) 20.7% require a permanent pacemaker
while 54.5% of non-AMI patients require a permanent pacemaker. In this study 27.6% of patients with AMI and a temporary
pacemaker died. AMI patients infrequently need a temporary pacemaker. In general, permanent pacemakers are better than
temporary pacemakers.
Risk Assessment:
There have been several hazards identified for this device. Biological hazards are deemed moderate because the severity of
the hazard is high but the probability of occurrence is low (table 2). Electrical hazards are estimated to be AFAP because of high
severity and low probability (table 2). These hazards must be avoided as a electric shock to the heart can be deadly. Maintenance
hazards are not likely to occur as long as the patient is following scheduled maintenance of the device.
Failure to deliver therapy and timely maintenance can be somewhat severe. Controls for these risks are listed in figure 3.
Post Market History:
According to the MAUDE database, only 7 reports have been made in the past 5 years regarding the device. A common issue was a malfunction
where the pacemaker was not pacing when needed. This was seen before the surgery and did not cause harm to the patient. Another issue is due
to operator mistake during insertion. The operator had perforated the the right ventricular, which eventually led to the death if the patient. Another
issue that has come up is the balloon not inflating when entering the tricuspid valve; this lead to an injury.
Conclusions
The Pacel Flow™ Directed Pacing Catheter is safe when looking at the reliability and effectiveness of the device. According to the Post Market History, the device has only had 1 issue in the past 5 years. From that valve embolization occurred and the issue was treated with fluoroscopy; a minimally invasive procedure. The overall residual risk of the device is low because of the positive relationship between the intended use and benefits. In the clinical effectiveness portion, studies have been stated that the use the device is better than the use of a temporary pacemaker and the use of the Pacel Flow Directed Pacing Catheter has been proven to be more beneficial than predicate devices. The temporary pacemaker was shown to have an increased mortality rate compared to the permanent pacemaker and the Pacel Catheter has also been more effective. According to the post market surveillance of the device, St. Jude, states that there are risk control measure such as site sterilization and limited magnetic field exposure taking place to ensure that the device is used with the patient’s safety paramount above all. Overall, the Pacel Flow™ Directed Pacing Catheter is a safe and effective device where the potential risks and hazards outweigh the benefits to the cardiovascular pacing it provides.
By: Vincent Cardenas, Dipan Patel, Hamza Shaheen, Ahmad Abushanab, Ericka Manalo
Department of Biomedical Engineering, San José State University
Works Cited
Table 2. Risk Assessment Diagram
Pacel Flow™ Directed Pacing Catheter Medical Device
Table 1. FMEA for Pacel™ Flow Directed Pacing Catheter
Fault Tree Analysis Diagram
Figure 1. Anatomy of a temporary pacemaker unit [4]
Figure 2. On the left is a picture of the Pacel™ Catheter [5] On the right is a figure demonstrating how the catheter is placed [6]
Figure 3. Risk Chart for the Pacel™ Flow Directed Pacing Catheter