FDA issues early alerts for intravascular catheters

Editor's Note

The US Food and Drug Administration (FDA) warned of safety risks resulting from manufacturing issues with two varieties of intravascular catheter—Conavi Medical’s Novasight Hybrid line and BD’s PowerPICC intravascular devices—in separate early alerts April 18.

In one reported incident, the sheath of a Novasight Hybrid catheter—a device used for imaging of coronary arteries—detached during use and was left in the patient’s body, FDA reports. Although the sheath was recovered and the patient uninjured, risks of such an incident include coronary artery spasm, dissection, perforation, thrombosis, embolism, and abrupt vessel closure, FDA reports. Removal also risks hemodynamic consequences such bradyarrhythmia and tachyarrhythmia, hypotension, and respiratory insufficiency, as well as surgical intervention if efforts fail. These devices should be removed from wherever they are used or sold. View the full announcement for specific lot numbers and other details.

Indicated for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, PowerPICC intravascular catheters should be destroyed if unused and carefully observed if in-use, per a letter from BD and subsidiary Bard Access Systems. As detailed in the FDA announcement, the warning is due to cracks in catheter bodies resulting in material fatigue leakage and potential for infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. 

BD has reported 10 serious injuries associated with this issue. The full FDA announcement provides additional details, including a picture of a typical catheter body crack and a complete list of affected devices.