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Inside Six-Year Probe of a Medical Device

Surgical Precision
Inside Six-Year Probe of Medical Device


SurgeonIt was a story in a Boston newspaper six years ago that piqued Nidia Gamba’s interest. On her way into work as a special agent in the FBI’s Boston field office, Gamba read that a local company’s medical device was failing during surgical procedures and that the Food and Drug Administration was inquiring about a voluntary recall.

The product in question was a delivery system used to implant stents in cardiac patients. A stent is an expandable wire mesh sheath placed within a blood vessel to keep it open or to clear a blockage. A catheter carries the stent to the affected area, and a tiny saline-filled balloon inside is inflated to expand the mesh and clear an opening. In this case, cardiologists were reporting unanticipated pinhole leaks and ruptures in the balloons, turning a fairly routine operation into a more risky endeavor.

Despite reports of complications, including one death, the company continued to ship the devices.

“It did not make sense to me that they were not recalling a product that was causing harm,” said Gamba, who before becoming an agent worked in the healthcare industry for 12 years and was a surgical sales specialist at a major pharmaceutical and medical device manufacturer.

Gamba called the U.S. Attorney’s Office in Boston, which concurred with the FDA inquiry and began what would become a six-year investigation involving hundreds of witness interviews in three countries and thousands of technical documents.

Here’s how the investigation worked:

  • With the FBI as the lead agency, the U.S. Attorney’s Office subpoenaed company e-mails, test results, clinical trials, sales figures, lot numbers, and other information covering the time when the stent was first developed to the time the defective devices were recalled.
  • Gamba and three FDA investigators waded through some 600 boxes of technical material looking for documentation that the company knowingly sold a defective product. They turned up evidence that during finished goods testing the devices failed up to 28 percent of the time-a rate that far exceeds the zero-percent guidelines issued by the FDA for Class III devices (devices that support or sustain human life). “They basically covered up and knew they were selling an adulterated product,” Gamba said.
  • The investigators interviewed every cardiologist who reported a problem and more than 100 employees at the company and its subsidiaries.

During the interviews, a designer acknowledged making the change that ultimately caused the device failures. Meanwhile, two employees told investigators they had urged management to cease shipping the devices. The company did finally stop shipments and issue a recall after distributing more than 34,000 flawed devices during a 54-day period in 1998.

Faced with mounting evidence, the company entered a settlement with the U.S. Attorney’s Office last June, agreeing to pay $74 million to the U.S., an amount equal to twice the sales revenue from shipments of the faulty devices.

“It was satisfying to see it all come to fruition,” said Gamba, who worked the case for three years before transferring to New York in 2001 and handing the investigation to another agent in Boston.

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