Edwards 9350BC16 Instrucciones De Uso página 2

6.0 Potential Adverse Events
Complications associated with standard catheterization, balloon aortic
valvuloplasty, and the use of angiography include, but are not limited to,
allergic reaction to anesthesia or to contrast media, injury including
perforation or dissection of vessels, thrombosis, emboli formation, renal
failure; renal insufficiency, and plaque dislodgement which may result in
myocardial infarction, stroke, and/or death . Additional complications may
include arrhythmia development, cardiac perforation, conduction system
injury, hematoma, infundibulum injury, annular tear or rupture and/or
valvular tearing or trauma .
7.0 Directions for Use
Dilate native valve leaflets using standard technique and rapid cardiac pacing .
Step Procedure
1 Prepare vascular access site for catheter insertion and position
guidewire using standard techniques .
2 With the balloon cover in place, flush the guidewire lumen of
the Edwards transfemoral balloon catheter with heparinized
saline . Attach a high pressure 3-way stopcock to the balloon
inflation port .
3 Prepare a syringe with diluted contrast solution (15:85 medium
to saline dilution) and attach to the stopcock .
4 Fill the inflation device with excess diluted contrast medium
relative to the indicated volume, attach in the locked position to
the stopcock, close the stopcock to the inflation device .
5 Slowly pull vacuum with the syringe repeatedly to remove air,
leaving zero pressure in the system .
6 Close the stopcock to the balloon catheter . Gradually remove
contrast medium into the syringe to achieve the appropriate
volume (as specified in Table 1: Inflation Parameters) . Lock the
inflation device, close the stopcock to the syringe and remove
the syringe from the system .
7 Remove the balloon cover and hydrate the length of the balloon
catheter .
8 Advance the balloon catheter over the guidewire, through the
introducer sheath, across the aortic valve, and position the
balloon markers at the intended site .
9 Ensure hemodynamic stability is established and begin rapid
pacing . Once the blood pressure has decreased to 50 mmHg or
below, balloon inflation can commence .
10 Fully and rapidly inflate the balloon with the inflation device . In
case of balloon instability, repeat balloon inflation while
ensuring rapid ventricular pacing . When the balloon is fully
deflated, the pacing should be turned off .
8.0 How Supplied
Supplied pouched and sterilized by ethylene oxide .
9.0 Storage
Store in a cool, dry place .
10.0 Device Disposal
Used devices may be handled and disposed of in the same manner as hospital
waste and biohazardous materials . There are no special risks related to the
disposal of these devices .
2