FDA > CDRH > Medical Device Safety > Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection

Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection

Intended Audience

Radiologists, Radiologic Technologists, and Radiologic Nurses
IV Team Nurses

This is to remind you of the potential for serious patient injury when vascular access devices not designed to tolerate high pressures are used for power injection of CT or MRI contrast media, and to recommend steps to avoid these injuries.

What’s the problem?

Over the past several years, we have received over 250 adverse event reports in which vascular access devices have ruptured when used with power injectors to administer contrast media as part of CT or MRI studies. These events have continued to occur despite rupture reports in the literature, letters from manufacturers, and warnings in power injectors’ labeling.

The ruptured devices have included central venous catheters, small gauge peripheral catheters, implanted ports, extension tubing and intravenous administration sets. Some of these ruptures have resulted in device fragmentation, sometimes with embolization or migration that required surgical intervention; extravasation of contrast media; loss of venous access requiring device replacement; and contamination of the room and personnel with blood and contrast media.

Why do ruptures occur?

The pressure required for contrast injection depends on many factors, including flow rate, contrast viscosity, tube diameter and length, and any obstruction to flow (e.g., kinks, curves, compression). To maintain the flow rate required for a CT or MRI study, a power injector may generate high pressures. Ruptures occur when the injection pressure exceeds the tolerance of the vascular access device(s).

Recommendations

To help prevent the rupture of vascular access devices when they are used with power injectors, users of these devices should:

1. Check the labeling of each vascular access device for its maximum pressure and flow rate. If none is provided, assume device is NOT intended for power injection and do not use.
    
2. Know the pressure limit setting for your power injector and how to adjust it.
    
3. Ensure that the pressure limit set for the power injector does not exceed the maximum labeled pressure for the vascular access device(s).

It is important to note that if the recommended pressure for a vascular access device is exceeded, the device may weaken even if no rupture is obvious, and the weakened device could fail to operate properly when it is used again.

Reporting to FDA

If you suspect that a death or serious injury was related to power injecting through a vascular access device, you should follow the mandatory reporting procedure established by your hospital or user facility.

For events that did not result in death or serious injuries, you can report directly to the device manufacturer or to MedWatch, the FDA’s voluntary reporting program. MedWatch can be contacted by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.

Updated July 7, 2004