NuMED PTS-X Série Mode D'emploi page 3

POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
Potential balloon separation following balloon rupture or abuse and the subsequent need to use a snare or other medical
interventional techniques to retrieve the pieces.
NOTE: There have been infrequent reports of larger diameter balloons bursting circumferentially, possibly due to a combination of tight
focal strictures in large vessels. In any instance of a balloon rupture while in use, it is recommended that a sheath be placed over the
ruptured balloon prior to withdrawal through the entry site. This can be accomplished by cutting off the proximal end of the catheter and
slipping an appropriately sized sheath over the catheter into the entry site. For specific technique, refer to: Tegtmeyer, Charles J., M.D. &
Bezirdijan Diran R., M.D. "Removing the Stuck, Ruptured Angioplasty Balloon Catheter." Radiology, Volume 139, 231-232, April 1981.
Potential complications & adverse effects associated with device use and indication include:
• Trauma and overstretching of the septum
• Device erosion
Any serious incident that has occurred in relation to the device should be reported to NuMED & the Competent Authority in the
country of use.
INSPECTION AND PREPARATION
1. Insert guidewire through the distal tip until guidewire exceeds proximal port.
2. Remove balloon protector. Inspect the catheter for damage prior to insertion.
3. Perform sizing using either a 1:3 or a 1:4 solution of saline and contrast medium, respectively.
4. Attach an inflation device with pressure gauge half filled with the contrast solution to the balloon port of the catheter.
5. Purge the catheter through lumen thoroughly, observing for leaks.
6. To check inflation/deflation times, use a stopwatch. Repeat the procedure several times to verify the inflation/deflation time.
7. Point the inflation device with pressure gauge nozzle downward and aspirate until all air is removed from the balloon, and
bubbles no longer appear in the contrast solution.
8. Turn the stopcock off to maintain the vacuum in the balloon.
9. Remove guidewire.
INSERTION: VASCULAR
1. Enter the vessel percutaneously using the standard Seldinger technique over a 0.035" superstiff wire positioned in the left upper
pulmonary vein or left atrial appendage.
2. Position the balloon across the defect and slowly inflate with diluted contrast. Both the Transesophageal echocardiogram (TEE)
and fluoroscopy monitor the inflation.
3. When the defect is completely occluded there will be no color flow shunt by TEE and a waist appears in the balloon.
4. The balloon waist size is measured by TEE or cineangiogram. This size corresponds to the stretched size of the defect.
DEFLATION AND WITHDRAWAL
1. Deflate the balloon by drawing a vacuum with an inflation device with pressure gauge. Note: The greater the vacuum applied and
held during withdrawal, the lower the deflated balloon profile.
2. Gently withdraw the catheter. As the balloon exits the vessel, use a smooth, gentle, steady motion. If resistance is felt upon
removal, then the balloon, guidewire, and the sheath should be removed together as a unit under fluoroscopic guidance,
particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon
catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.
3. Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous vascular procedures.
4. Dispose of device after use according to standard hospital protocol for biohazardous devices.
WARNING: NuMED catheters are placed in the extremely hostile environment of the human body. Catheters may fail to function for a
variety of causes including, but not limited to, medical complications or failure of catheters by breakage. In addition, despite the
exercise of all due care in design, component selection, manufacture and testing prior to sale, catheters may be easily damaged
before, during, or after insertion by improper handling or other intervening acts. Consequently, no representation or warranty is made
that failure or cessation of function of catheters will not occur or that the body will not react adversely to the placement of catheters or
that medical complications will not follow the use of catheters.
NuMED cannot warrant or guarantee NuMED accessories because the structure of the accessories may be damaged by improper
handling before or during use. Therefore, no representations or warranties are made concerning them.
Catheters and accessories are sold in an 'as is' condition. The entire risk as to the quality and performance of the catheter is with the
buyer. NuMED disclaims all warranties, expressed or implied, with respect to catheters and accessories, including but not limited to,
any implied warranty of merchantability or fitness for a particular purpose. NuMED shall not be liable to any person for any medical
expenses or any direct or consequential damages resulting from the use of any catheter or accessory or caused by any defect,
failure, or malfunction of any catheter or accessory, whether a claim for such damages is based upon warranty, contract, tort, or
otherwise. No person has any authority to bind NuMED to any representation or warranty with respect to catheters and accessories.
Applied
10.0 (mm)
Pressure
0.5 ATM 8.35
1.0 ATM 9.16
1.5 ATM 9.67
2.0 ATM 10.08
2.5 ATM 10.37
The figures in bold face represent the balloon diameter @ Rated Burst Pressure.
Warranty and Limitations
PTS-X™ Balloon Sizing Chart
12.0 (mm) 15.0 (mm)
9.77 12.57
10.57 13.59
11.43 14.82
12.03 15.52
FOR ALL NuMED CATHETERS AN INFLATION DEVICE
WITH PRESSURE GAUGE SHOULD BE USED.
• Device embolization
• Access site complications
20.0 (mm) 25.0 (mm)
- -
19.87 24.81
20.86 26.56
3
30.0 (mm) 35.0 (mm)
- 31.74
30.12 34.28
40.0 (mm)
38.72