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Central Vascular Access Devices - Complications of Catheter Pinch-off - Notice to Hospitals

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Contact: Marketed Health Products Directorate

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Notice to Hospitals
Health Canada Issued Important Safety Information on Central Vascular Access Devices

August 22, 2011

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Radiology, Emergency Medicine, Intensive Care, Nursing and other involved professional staff and post this NOTICE in your institution.

Subject: Complications of Catheter Pinch-off Associated with Central Vascular Access Devices

Despite the fact that central vascular access devices (also known as central venous catheters or implantable ports) are considered to be safe and represent convenient means for providing patients with intravenous medication therapies, Health Canada is concerned about Canadian reports of catheter pinch-off (compression and fracture of the catheter), leading to subsequent embolization of the fractured distal fragments.

These devices are commonly used to provide convenient repeated access to the vascular system for the delivery of medications, fluids, parenteral nutrition solutions and frequent blood sampling. Catheter pinch-off related problems can present as an inability to aspirate blood from a catheter line or injection port, or occasionally as chest pain or cardiac arrhythmias during infusion procedures. The presentation of catheter pinch-off related problems are quite variable as some patients with a fractured catheter can remain asymptomatic. Most of the reported cases involved migration of a fractured catheter to the pulmonary artery or the heart.

In order to minimize the risk of these complications associated with the use of central vascular access devices, Health Canada recommends the following:

  1. Review the labelling of relevant devices, especially sections concerning warnings and implantation instructions.
  2. Remain vigilant for early signs of catheter pinch-off problems. 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, and perform chest radiograph as needed to rule it out.
  3. Consider a follow up with chest radiograph in patients with long-term central vascular access devices.  Educate patients to inform healthcare professionals when experiencing pain or other abnormal symptoms upon flushing or infusion of fluids through the catheter line.

Catheter pinch-off related problems may result from the gradual breakdown of the catheter line following mechanical compression between the clavicle and the first rib. Caution should be taken when choosing the vein for catheter insertion as catheter pinch-off related problems have been reported when the subclavian vein has been used. Catheter 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.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients implanted with central vascular access devices should be reported to Health Canada at the following address:

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738