Cath Lab Digest

1. Carefully inspect the package to assure that the integrity of the sterile packaging. Do not use the product if there are any signs of damage.
2. Do not use after the “Use By” or “Expiration” date. Sometimes this date is identified by the hourglass sign. Don’t confuse this icon with the “manufactured date” icon (Figures 1-2).
3. If you have a “pouch in a pouch” product, the outside of the inner pouch is not sterile. It is packaged this way in order for the drug-eluting stent to maintain the medication.
4. Carefully remove the delivery system from the protective tubing. If a monorail (Rx), do not bend or kink the hypotube during removal (Figure 3).
5. Remove the product mandrel and/or protective sheath that may be present on the product (Figure 4).
6. a.    For over-the-wire (OTW) products, flush the guide wire lumen with a heparin/normal saline mixture until fluid exits the distal end of the delivery system (Figure 5). 

    b.    For monorail (Rx) products, flush the guide wire lumen with a heparin/normal saline mixture using the flushing tool provided with the product. Insert the flushing tool into the tip of the catheter and flush until fluid exits the guide wire exit notch (Figures 6-8).

7. Prepare an inflation device/syringe with diluted contrast medium. Note: Most manufacturers will not specifically state the concentration. My experience has shown most facilities will use a 50/50 mixture (Figures 9-10).
8. Attach an inflation device/syringe to the stopcock; attach it to the inflation port of the product. Do not bend the product hypotube when connecting to the inflation device/syringe (Figures 11-12). 
9. With the tip down, orient the delivery system vertically (Figure 13).
10. Open the stopcock to the delivery system; pull negative for 15-30 seconds; slowly release to neutral for contrast fill of the delivery system tube (Figures 14-15).
11. Close the stopcock to the delivery system; purge the inflation device/syringe of all air.
12. Repeat steps 9-11 until all air is expelled. If bubbles exist, do not use the product.
13. If a stopcock was used, attach a prepared inflation device to the stopcock. Utilize a “meniscus to meniscus” connection whether connecting to a stopcock or directly to the delivery system (Figures 16-17).  
14. Open the stopcock to the delivery system.
15. Leave on “neutral.”
16. STENTS: While introducing the delivery system to the vessel, do not induce negative pressure on the delivery system. This may cause dislodgement of the stent from the balloon.
17. If air is seen in the shaft of the delivery system, repeat instructions above to prevent uneven balloon/stent expansion.
18. Backload the delivery system onto the proximal portion of the guide wire while maintaining guide wire positioning across the target lesion.
19. Carefully advance the product to the target lesion.

Note: Most manufacturers have specific IFU/DFU for the inflation and deployment process. The scope of this article is for the preparation of the balloon. Refer to the IFU/DFU for further directions on deployment procedures.

Hopefully, the list above will help you navigate the proper preparation of balloons (with and without stents).  Understanding the manufacturer’s IFU/DFU can be confusing, but realize that they are mostly the same.

We need your questions! No question too big or small. Please do not hesitate to send a question to Cath Lab Digest via cathlabdigest@aol.com or to me directly, at tginapp@rcisreview.com.

Sample Vendor List for IFUs/DFUs (with shortened website addresses)

Medtronic Driver (http://bit.ly/GBmqxF)
http://manuals.medtronic.com/wcm/groups/mdtcom_sg/@emanuals/@era/@cardio/documents/documents/m707281b001_cont_20071018.pdf

Medtronic Resolute Integrity  (http://bit.ly/GBulwc)
http://manuals.medtronic.com/wcm/groups/mdtcom_sg/@emanuals/@era/@cardio/documents/documents/contrib_109182.pdf

Cordis Firestar/Durastar  (http://bit.ly/GDkKGX )
http://www.cordis.com/products/dura-star-ptca-dilatation-catheters/epi

Boston Scientific Promus Element  (http://bit.ly/GAXNnx)
http://www.bostonscientific.com/Device.bsci?page=ResourceDetail&navRelId=1000.1003&method=DevDetailHCP&id=10154661&resource_type_category_id=1&resource_type_id=82&pageDisclaimer=Disclaimer.ProductPage