Recalled CardioGen-82 Caused Radiation Overdoses in Cardiac PET Scan Patients

The CardioGen-82, a device used in cardiac positron-emission tomography (PET) scans, was recalled in July, after several patients who underwent the scans suffered <"">radiation overdoses. At the time, the U.S. Food & Drug Administration (FDA) said that a “strontium breakthrough” problem with the device may have resulted in two patients receiving more strontium than expected.

Cardiac PET scans are a highly accurate way to detect heart malfunctions because they can measure blood flow through the organ. CardioGen-82 is used to infuse a radioactive chemical into a patient, and the chemical’s movement is tracked by the scanner.

According to a report from the Herald-Tribune, the two patients received “breakthrough” radiation from devices that were used for too long because replacements were unavailable. The radiation overdoses where discovered in when the patients were stopped in June at the Canadian border after setting off gamma ray emission sensors. Both turned out to have been treated with the CardioGen-82.

One of the patients had been treated at Heart Specialists of Sarasota in Florida, and the other in Nevada. After the FDA began its investigation, it learned that a third international patient who also underwent a scan at Heart Specialists of Sarasota had triggered an alarm when returning to the United States, the Herald-Tribune said.

All three of the patients underwent their scans in February. Strontium, in minute amounts, is an unavoidable byproduct of these types of scans. Normally though, the radiation only stays in the body for a day or two, but for these three patients, it remained detectable for months.

PET scans are considered preferable to CT (computed tomography) scans because they generally involve lower radiation exposures. But an expert told the Herald-Tribune that radiation in the two Sarasota patients was similar to what they would have received in a CT scan. In a letter to patients, Bracco Diagnostics, the maker of the CardiGen-82 device, said it would take a higher dose to cause an adverse reaction.

Heart Specialists started using the CardioGen-82 in November 2010. According to the Herald-Tribune, the particular device that overexposed the two Heart Specialists patients was placed into use on January 8, 2011. The devices have a 28-day expiration limit, but a manufacturing issue caused Bracco to extend that to 45 days, something which it says the FDA “was on board with.” The two Heart Specialist patients who received radiation overdoses were scanned on February 17 and 23, 40 and 44 days after the CardioGen device was put into service.

According to the Herald-Tribune, Bracco told state investigators that its revised use period was 42 days, and that Heart Specialists had exceeded that limit.

According to the Herald-Tribune, Heart Specialists of Sarasota has contacted 30 patients who were also scanned in late February, and is awaiting final results of their screenings.

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