Canada Warns of Central Vascular Access Device Complications

A warning has been issued to surgery, radiology, emergency medicine, intensive care, nursing, and other professional staff departments concerning complications of catheter pinch-off linked to central vascular access devices.

Health Canada wrote that while central vascular access devices—also known as central venous catheters or implantable ports—are generally considered safe and representing a convenient way to administer intravenous medication therapies to patients, Health Canada is concerned about Canadian reports of catheter pinch-off. Catheter pinch-off—a compression and fracture of the catheter—has been reported to lead to subsequent embolization of the fractured distal fragments.

These devices are commonly used to provide convenient, repeated access to the patient’s vascular system for the delivery of medications, fluids, parenteral nutrition solutions, and recurrent blood sampling. Catheter pinch-off related problems can create a situation in which blood cannot be aspirated from a catheter line or injection port, or can occasionally cause chest pain or cardiac arrhythmias during infusion.

Catheter pinch-off related problems can vary from patient-to-patient. Some patients with a fractured catheter may not present with symptoms. Most reported cases, however, involve migration, or movement, of a fractured catheter to the pulmonary artery or the heart. To minimize the risk for these complications linked to use of central vascular access devices, Health Canada recommends:

• Review device labeling, especially sections about warnings and implantation instructions.

• Remain vigilant for early signs of catheter pinch-off problems and stop using the catheter line when blood cannot be aspirated from the catheter, when the catheter cannot be flushed easily, and/or whenever a catheter pinch-off related problem is suspected. Perform chest radiographs, as needed, to rule out a catheter pinch-off problem.

• Consider a follow-up chest radiograph in patients with long-term central vascular access devices and educate patients about advising healthcare professionals when they experience pain or other abnormal symptoms when the catheter line is flushed or fluids are infused.

Catheter pinch-off related problems occur because of the gradual breakdown of the catheter line after mechanical compression between the clavicle and the first rib. When choosing the vein for catheter insertion, care should be taken, since pinch-off related problems have been reported when the subclavian vein was used.

Pinch-off may also cause disconnection or fracture at the junction of the injection port chamber and the catheter due to the compression between the fixed injection port chamber and the movable catheter with shoulder movements.

Cases of serious or unexpected adverse incidents in patients implanted with central vascular access devices should be reported to Health Canada at: Health Products and Food Branch Inspectorate; Health Canada; Address Locator: 2003D; Ottawa, Ontario K1A 0K9.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.