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Federal law (U.S.) restricts this device to sale by, or on the order of, a physician.
See product catalog for reorder numbers.
See individual sterile package label for contents.
Single-use disposable medical device. Contents are sterile if package is unopened and undamaged.
Do not resterilize.
DESCRIPTION
The St . Jude Medical PACEL™ Flow Directed Pacing Catheter (FDPC) is designed to establish temporary right ventricular
pacing with or without using fluoroscopy guidance for placement . Catheters are depth marked as an aid in catheter placement
under fluoroscopy . Electrodes at the catheter tip enable ECG monitoring and bipolar pacing . An inflatable balloon, located
between two platinum electrodes, allows for flow directed positioning that aids the operator in crossing the tricuspid valve and
directing the catheter towards the right ventricular apex, without the use of fluoroscopy . Once the catheter has crossed the
valve, the balloon is deflated and the catheter is advanced to the right ventricular apex in the usual manner . Electrograms are
monitored to verify proper positioning in the right ventricular apex and pacing thresholds are obtained to confirm both proper
location and reliable pacing .
The nominal length of the catheter is 110 cm, and the diameter of the catheter is 5 French . The catheters are available in two
curve styles: Straight Tip and Right Heart Curve . The functional end of the catheter includes a platinum electrical connector
ring and a tip electrode on the distal end of the catheter . The proximal end of the catheter includes a two pin electrical
connector . The electrical signals can be transmitted to external equipment or from external equipment to the heart .
INDICATIONS FOR USE
St . Jude Medical Pacel™ Flow Directed Bipolar Pacing Catheters are indicated for use in temporary, transvenous right
ventricular pacing .
CONTRAINDICATIONS
Patients with recurrent sepsis or with a hypercoagulable state should not be considered candidates for transvenous catheters
since the catheter could serve as a focal point for septic or bland thrombus formation . In addition, patients with tricuspid valve
prosthesis should not be considered for ventricular pacing .
WARNINGS
•
Misuse of this catheter and accessories may result in serious complications .
•
Use of this device should only extend to those physicians who are skilled in the techniques of transvenous intracardiac
studies and temporary pacing .
•
Pacel temporary pacing catheters are MRI unsafe .
•
For Single Use Only! Single-use devices are designed and tested for only one patient application . These are disposable
devices and are not designed for reprocessing and reuse . Reuse of designated "single-use" devices creates a risk of
patient or user infections due to prior patient use and the difficulty in cleaning the narrow structures at material interfaces
following direct blood contact . Contamination or reprocessing cleaning agent residues may lead to adverse patient
reactions and may damage the device . Use of non-St . Jude Medical packaging may compromise device functionality and
sterility due to compromised protection from shipping and handling damage . The absence of labeling after reprocessing,
may lead to misuse of the device and impaired traceability . Reprocessing and reuse may result in patient or user injury,
permanent impairment or death .
PRECAUTIONS
•
Do not alter this device .
•
For specific details in the use of electrophysiology catheters and the techniques employed in an electrophysiology study,
the physician should be referred to the medical literature and rely on training and practical experience .
•
The presence of pre-existing left bundle branch block predisposes the patient to the risk of transient complete heart block
when positioning a catheter in the right ventricle .
•
This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
•
Isolated or battery powered equipment is recommended for use with intracardiac catheters .
•
This device should only be used with equipment that complies with international safety standards .
•
Proper electrical functioning of this device requires that you handle the Flow Directed Pacing Catheter with care .
Stretching and/or kinking while wiping may result in damage .
•
DO NOT wipe Flow Directed Pacing Catheter with organic solvents (alcohols, ethers, esters, phenols, etc . ) or alcohol
base antiseptics .
•
Temporary pacing leads which are indwelling for extended periods of time (greater than 72 hours) should be routinely
evaluated and replaced as needed .
•
Knotting and Looping. Knotting of flexible catheters is possible after looping an excessive or redundant length of
catheter during insertion . To prevent knots, avoid inserting redundant lengths of catheter . If a loop is suspected, retract the
catheter to the right atrium and reposition . If a knot exists and it is free of intracardiac structures, it can be gently withdrawn
through the site of entry .
•
Balloon Inflation. DO NOT USE A LIQUID FOR BALLOON INFLATION. If balloon reinflation is required, ensure that
the balloon is fully deflated . DO NOT OVERINFLATE THE BALLOON.
•
Deflate balloon prior to withdrawal of catheter .
•
Use ECG or fluoroscopy when advancing catheter and to confirm placement .
•
The Pacel™ Flow Directed Pacing Catheter has been sterilized with ethylene oxide prior to shipment .
POTENTIAL COMPLICATIONS
General complications associated with the use of indwelling transvenous pacing catheters include:
•
Arrhythmias
•
Arteriovenous Fistula Formation
•
Cardiac Tamponade
PACEL™
Flow Directed Pacing Catheter
Instructions for use
•
Damage to Vessels or Valve Structures
•
Diaphragmatic Stimulation
•
Endocarditis
•
Endocardial Perforation
•
Knotting of the catheter
•
Pneumothorax
•
Sepsis/Infection
•
Thrombocytopenia
•
Thrombophlebitis
•
Thrombosis
RECOMMENDED EQUIPMENT
•
ECG Monitor
•
External Pacemaker (Pulse Generator)
•
Defibrillator and respiratory assist equipment and/or anti-arrhythmia drugs should be readily available in the event
complications arise during catheter placement .
SUGGESTED DIRECTIONS FOR USE
Preparation and Testing. Prior to catheter introduction, test balloon integrity by inflating and deflating while balloon is
submerged in sterile saline or water . Use correct inflation volume of 1 . 2 5 cc . DO NOT OVER-INFLATE. If balloon leaks
(bubbles visible while inflated balloon is submerged in sterile saline or water), do not use the catheter .
The medical techniques and procedures described in these Instructions for Use do not represent ALL medically acceptable
protocols, nor are they intended as a substitute for the clinician's experience and judgment in treating any specific patient .
1 .
Insertion of this device into the right ventricle can be performed at the patient's bedside (generally without the use of
fluoroscopy) by ECG monitoring .
2 .
The pacing catheters should be introduced via appropriate size percutaneous introducer assembly or a cutdown .
3 .
If introducer set provided with the kit is used, proceed as follows .
4 .
Insert needle/sheath into vessel and observe venous return .
Note: A syringe may be attached to the needle to add stability during insertion and to enable verification of venous return .
CAUTION: INSERTION INTO ARTERY MAY CAUSE EXCESSIVE BLEEDING AND/OR OTHER COMPLICATIONS.
5 .
Remove the needle leaving introducer sheath in place . Place thumb over the exposed orifice of the sheath to reduce air
aspiration and/or blood loss .
CAUTION: DO NOT RE-INSERT NEEDLE WHILE SHEATH IS IN VEIN.
6 .
Having tested the balloon, insert and advance catheter .
CAUTION: DO NOT USE FORCEPS TO ADVANCE CATHETER.
7 .
Advance the catheter into the vein .
8 .
Connect the distal tip electrode to the V lead of an isolated ECG monitor .
Optional: An adapter is provided in the PACEL™ FDPC package for this purpose, if required .
9 .
Advance the catheter into the right atrium, ECG monitoring (Figure 1) and/or fluoroscopy can be used while advancing
catheter . When the catheter enters the right atrium, a large atrial complex (P-wave) is indicated . Catheters are depth
marked as an aid in catheter placement
Superior
Vena Cava
10 . While monitoring the ECG at the catheter's distal tip, inflate the balloon to its recommended inflation volume and advance
the catheter into the right ventricle . Upon entry in to the ventricle, immediately deflate the balloon to prevent continued
passage into the pulmonary outflow tract . Entry in the right ventricle is evidenced by an increase in the ventricular
complex and a decrease in the amplitude of the atrial complex .
Note: It may be necessary to reinflate the balloon if extended periods of inflation are required . Completely deflate the
balloon prior to reinflation .
2
Figure 1
DEPTH MARK CODE – 10 CM (NOT TO SCALE)
DISTAL END
High
Middle
Right
Right
Atrium
Atrium
Right
Right
Ventricular
Ventricular
Cavity
Endocardium
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