EMMC Device Investigation Triggers North American Recall and Award from FDA


(Bangor, Maine) - It’s not often that the US Food and Drug Administration calls out a hospital for its contribution to the promotion of patient safety, but it happened recently to Eastern Maine Medical Center and EMMC Risk Management coordinator Cheryl Long, RN, LNCC, CPHRM.

Cheryl investigated the Cordis Optease Vena Cava Filter after Daniel O’Brien, MD, diagnostic radiologist, Spectrum Medical Group, alerted EMMC’s Risk Management to a potential issue. This medical device is inserted into a vein that returns blood to the heart from the legs. It catches blood clots so they do not move through the body and prevents a recurrent pulmonary embolism—a life threatening condition.

After discovering a problem with the implantation of the device, Cheryl submitted a voluntary report to the FDA detailing the investigation carried out at EMMC, which included photographs of the product labeling. The FDA was then able to determine that the device had been mislabeled by the manufacturer and responded by issuing a Class 1 Recall, which removed the product from hospitals in the US, Canada, and Panama.
No EMMC patients sustained any injury due to this medical device issue.

“We are always on the lookout for medical devices that don’t work properly. It’s important to get them flagged early before any patient has an adverse event,” says Cheryl. “It’s part of our commitment to patient safety, and we’re doing it every day.”
Other EMMC healthcare professionals who participated in identifying the issue with the Vena Cava Filter were: David Burke, MD, FACS, Surgery and Trauma Specialist of Maine; James Clarke, MD, FACS, Northeast Surgery of Maine; Mark Grant, MD, Surgery and Trauma Specialists of Maine; and David Ahola, MD, Chief of Radiology.

All hospitals are required by law to report medical device adverse events to the US Food and Drug Administration under the Safe Medical Devices Act. Since 2004, EMMC has taken its commitment to safety further by voluntarily reporting medical device issues before any injuries can occur as part of the FDA’s MedSun program, a step above the national standard. This advocacy is part of a culture of safety at EMMC and throughout EMHS that focuses on many measures that provide the highest quality healthcare for our patients.