I'm looking for anyone who works in a Trauma center that regularly used Cordis (Percutaneous Sheath) or MAC (multi access Catheters) . These 9Fr catheters are placed mostly for Trauma patients for volume resuscitation. The brand we use is Arrow (Teleflex medical). The problem with these large bore lines is that they are not pressure rated for CT Power injection which as you can imagine is a problem when a sick patient heads to CT and they have no other access. Common sense may dictate that these are very large bore catheters and should be fine but the company will not make such a recommendation and just say that they are NOT approved for power injection. We have used these catheters for power injection but when we contacted Arrow - they are not pressure rated. Often with these patients it would delay care to delay the CT to try to find a PIV just to pressure inject. This question comes up periodically and we are now taking it to our risk management team for advise.
Question:
Do other facilities power inject through these catheters anyway?
Do other facilites use another brands of big Fr catheters that are pressure rated?
Any information would be appreciated.
Thank you
Be careful. utilizing a device outside the IFU and with a complication has serious repercussions. Fracture of a catheter is your greatest risk. If the cord is is not made of the same material as other powered catheters and not tested and that catheter fractured no one will stand behind you if serious consequences happen. ( foreign body embolus and possible death of a patient )
Teleflex/arrow have many power devices. I urge you to explore replacing these cordis with a power counterpart. We recently switched to the power TLC from arrow
I was an IR nurse for years and had my fair share of call ins for fractured nonpowereed catheter being used in this manner. Take the 5 minutes and gain a PIV (ultrasound can become your friend ) versus spending hours resuscitating /retrieving that piece of catheter .
Pamela Buhidar
It might be helpful to clarify some terms first. "Cordis" is a brand name, they make Percuteneous Sheath Introducers among a number of other products, for whatever reason "Cordis" is a commonly used term to refer to an Introducer in the IJ, even though when the same Introducer is placed elsewhere it's usually just called an Introducer or Sheath. Introducers are used in various patient groups other than trauma.
It's also important to understand the difference between IFUs (Instructions For Use) and FDA approved labelling indications. FDA approved labelling indications only refer to what the product can be marketed for, not what it can be used for. Going against what IFUs reccomend and "off-label" use are two very different things. Manufacturers choose what indications to seek marketing approval for based on their return on the cost of gaining approval, not on whether it is safe to use for that purpose.
Using an Introducer for the primary purpose of volume resuscitation in a trauma patient for instance is an off-label use, and it's unlikely that being able to market introducers as "pressure rated" is enough of a driver of the decision to purchase these products to make it worth-their-while to go through the labelling approval process, but that doesn't really have anything to do with whether they are safe to use for this purpose.
The PSI that a line can withstand only comes into play when the flow rate is exceeded, and the flow rate of 9 Fr introducer is about 10 times that of a peripheral IV rates for pressure injection.